American Micro Scan: FDA filings under this applicant name
FDA lists 24 510(k) clearances under the applicant name “American Micro Scan” (first 1983, latest 1987), plus 1 PMA decision, across 20 product codes in 3 review panels. Median 510(k) review time under this name: 55 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JWY | Manual Antimicrobial Susceptibility Test Systems | 3 | 3 |
| JTO | Discs, Strips And Reagents, Microorganism Differentiation | 2 | 2 |
| LJP | Antiserum, Fluorescent, Chlamydia Trachomatis | 2 | 2 |
| GRP | Antisera, All Types, H. Influenza | 1 | 1 |
| GTZ | Antisera, All Groups, Streptococcus Spp. | 1 | 1 |
| GWC | Antisera, All Types, Streptococcus Pneumoniae | 1 | 1 |
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 1 | 1 |
| JSE | Culture Media, Multiple Biochemical Test | 1 | 1 |
| JSM | Culture Media, Non-Propagating Transport | 1 | 1 |
| JSP | Kit, Anaerobic Identification | 1 | 1 |
Plus 10 more product codes.
Review panels
- Microbiology (20)
- Pathology (2)
- Clinical Chemistry (1)
Most recent American Micro Scan 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K870029 | IMMUNOSCAN(TM) DIRECT STREPTOCOCCUS PNEUMONIAE | GWC | 1987-03-25 | 79 |
| K864662 | CHLAMYDIAE FLUOR. AB TEST FOR DETECTION IN SMEARS | LJP | 1987-03-25 | 117 |
| K863776 | MICRODILUTION MIC PANELS | JWY | 1987-02-02 | 130 |
| K864674 | MICRODILUTION IDENTIFICATION PANELS | JSE | 1987-01-05 | 34 |
| K864389 | CHLAMYDIAE FLOURESCENT MONOCLONAL ANTIBODY TEST | LJP | 1986-12-04 | 28 |
| K863038 | GRAM POSITIVE FLUORESCENT IDENTIFICATION PANEL | LQL | 1986-09-30 | 49 |
| K862642 | GRAM NEGATIVE FLUORESCENT IDENTIFICATION PANEL | LQM | 1986-09-11 | 62 |
| K862332 | ANAEROBE RAPID CHROMOGENIC ID PANEL | JSP | 1986-08-27 | 69 |
| K862140 | MICRODILUTION PANELS | JWY | 1986-07-16 | 42 |
| K861584 | GRAM NEGATIVE COMBO PANEL TYPE 3 | JWY | 1986-06-17 | 49 |
14 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| N62160 | PMA | MIC PANELS | 1979-04-04 |
Recalls
openFDA lists no recalls under a recalling firm named American Micro Scan.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- American Dade (149 510(k)s)
- American Edwards Laboratories (89 510(k)s)
- American Medical Systems, Inc. (82 510(k)s)
- American Bioproducts Co. (79 510(k)s)
- American Monitor Corp. (73 510(k)s)
- American Pharmaseal Div. Ahsc (64 510(k)s)
- American Bentley (59 510(k)s)
- American Hospital Supply Corp. (56 510(k)s)
- American Research Products Co. (56 510(k)s)
- American Orthodontics (46 510(k)s)
- American Diagnostic Corp. (39 510(k)s)
- American Laboratory Supply, Inc. (36 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under American Micro Scan?
FDA lists 24 510(k) clearances under the applicant name “American Micro Scan” (first 1983, latest 1987), plus 1 PMA decision, across 20 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by American Micro Scan?
The median time from FDA receipt to decision across 510(k)s cleared under the name American Micro Scan is 55 days.
Which FDA product codes appear under American Micro Scan?
The most frequent FDA product codes under this applicant name are JWY (Manual Antimicrobial Susceptibility Test Systems, 3); JTO (Discs, Strips And Reagents, Microorganism Differentiation, 2); LJP (Antiserum, Fluorescent, Chlamydia Trachomatis, 2).
Next steps
- See all 24 American Micro Scan clearances with predicates and recalls
- Run predicate analysis for product code JWY, American Micro Scan's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.