Analytical Products, Inc.: FDA filings under this applicant name
FDA lists 57 510(k) clearances under the applicant name “Analytical Products, Inc.” (first 1976, latest 1993), plus 2 PMA decisions, across 29 product codes in 6 review panels. Median 510(k) review time under this name: 36 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 | 11 | 10 |
| JTO | Discs, Strips And Reagents, Microorganism Differentiation | 6 | 6 |
| JSE | Culture Media, Multiple Biochemical Test | 5 | 5 |
| GTQ | Antistreptolysin - Titer/Streptolysin O Reagent | 3 | 3 |
| JJS | Controls For Blood-Gases, (Assayed And Unassayed) | 3 | 3 |
| LTW | Susceptibility Test Cards, Antimicrobial | 3 | 3 |
| CHL | Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | 2 | 2 |
| JSP | Kit, Anaerobic Identification | 2 | 2 |
| JTC | Device, Microtiter Diluting/Dispensing | 2 | 2 |
| JTL | Plasma, Coagulase, Human, Horse And Rabbit | 2 | 2 |
Plus 19 more product codes.
Review panels
- Microbiology (44)
- Clinical Chemistry (9)
- Anesthesiology (2)
- Hematology (1)
- General and Plastic Surgery (1)
- Clinical Toxicology (1)
Most recent Analytical Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K924814 | API 20E/UNISCEPT 20E | JSS | 1993-03-11 | 167 |
| K923684 | API UNISCEPT MIC/TYPE 2 AND 3 AND MICRO MIC | JWY | 1992-12-03 | 133 |
| K922926 | API UNISCEPT KB/TYPE 2 AND 3 | JWY | 1992-10-13 | 118 |
| K901559 | MODIFICATION TO API UNISCEPT 20GP | LQL | 1990-09-10 | 160 |
| K901390 | DMAC INDOLE REAGENT | JTO | 1990-04-16 | 21 |
| K895796 | API UNISCEPT KB | JWY | 1989-11-13 | 46 |
| K884510 | MODIFICATION MICRO-MIC | JWY | 1988-11-22 | 26 |
| K884509 | MODIFICATION MIC/API UNISCEPT(R) | JWY | 1988-11-22 | 26 |
| K880598 | MODIFICATIONS TO API UNISCEPT (R) KB | JWY | 1988-03-23 | 41 |
| K874466 | API UNISCEPT(R) MICRO-MIC(R) SYSTEM/UNISCEPT MIC | JWY | 1987-12-09 | 37 |
47 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P830028 | PMA | UNISCEPT(TM) | 1984-03-01 |
| P800029 | PMA | API 3600S ANTIMICROBIAL SUSCEPTIBILITY SYSTEM | 1981-01-30 |
Recalls
openFDA lists no recalls under a recalling firm named Analytical Products, Inc..
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.
- Analytical Control Systems, Inc. (42 510(k)s)
- Analytical & Research Chemicals, Inc. (12 510(k)s)
- Analytical Industries, Inc. (3 510(k)s)
- Analytical Luminescence Laboratory, Inc. (2 510(k)s)
- Analytical Development Assoc. Corp. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Analytical Products, Inc.?
FDA lists 57 510(k) clearances under the applicant name “Analytical Products, Inc.” (first 1976, latest 1993), plus 2 PMA decisions, across 29 product codes in 6 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 Analytical Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Analytical Products, Inc. is 36 days.
Which FDA product codes appear under Analytical Products, Inc.?
The most frequent FDA product codes under this applicant name are JWY (Manual Antimicrobial Susceptibility Test Systems, 11); JTO (Discs, Strips And Reagents, Microorganism Differentiation, 6); JSE (Culture Media, Multiple Biochemical Test, 5).
Next steps
- See all 57 Analytical Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JWY, Analytical Products, Inc.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.