Scott Laboratories, Inc.: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “Scott Laboratories, Inc.” (first 1976, latest 1988), plus 1 PMA decision, across 13 product codes in 2 review panels. Median 510(k) review time under this name: 32 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 |
|---|---|---|---|
| JTO | Discs, Strips And Reagents, Microorganism Differentiation | 5 | 5 |
| GQL | Antisera, Fluorescent, Herpesvirus Hominis 1,2 | 1 | 1 |
| GTZ | Antisera, All Groups, Streptococcus Spp. | 1 | 1 |
| JSH | Culture Media, Non-Selective And Differential | 1 | 1 |
| JSJ | Culture Media, Selective And Non-Differential | 1 | 1 |
| JTS | Stains, Microbiologic | 1 | 1 |
| JTX | Transport Systems, Anaerobic | 1 | 1 |
| JTY | Culture Media, For Isolation Of Pathogenic Neisseria | 1 | 1 |
| JWX | Kit, Screening, Staphylococcus Aureus | 1 | 1 |
| KZJ | Device, Gas Generating | 1 | 1 |
Plus 3 more product codes.
Review panels
- Microbiology (16)
- Anesthesiology (1)
Most recent Scott Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K880694 | B. CAT CONFIRM | JTO | 1988-06-16 | 115 |
| K874933 | MUG-INDOLE DISC | JTO | 1988-01-05 | 32 |
| K874662 | MYCO-FLUOR REAGENT A & B | JTS | 1987-11-25 | 12 |
| K873509 | IDENTICULT-BL | JTO | 1987-10-15 | 45 |
| K871238 | ANABAG | KZJ | 1987-04-03 | 7 |
| K863025 | SERO-STAT R II STAPHYLOCOCCUS TEST | LHT | 1986-09-15 | 35 |
| K852869 | SELECTICULT-CHLAMYDIA | LKH | 1985-09-19 | 73 |
| K852832 | IDENTICULT-NEISSERIA | JTO | 1985-07-19 | 17 |
| K852666 | IDENTICULT-AE | JTO | 1985-07-15 | 21 |
| K841680 | SCOTT SELECTICULT-HSV ISOLATION & | GQL | 1984-10-30 | 190 |
6 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P080009 | PMA | SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM | 2013-05-03 |
Recalls
openFDA lists no recalls under a recalling firm named Scott Laboratories, 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.
- Scott Health Care (9 510(k)s)
- Scott Imaging Intl., Inc. (7 510(k)s)
- Scott Paper Co. (3 510(k)s)
- Scott All-Sports, Inc. (2 510(k)s)
- Scott E Allen CP (1 510(k)s)
- Scott Feldman Dds & Norman Shapiro Dds (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Scott Laboratories, Inc.?
FDA lists 16 510(k) clearances under the applicant name “Scott Laboratories, Inc.” (first 1976, latest 1988), plus 1 PMA decision, across 13 product codes in 2 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 Scott Laboratories, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Scott Laboratories, Inc. is 32 days.
Which FDA product codes appear under Scott Laboratories, Inc.?
The most frequent FDA product codes under this applicant name are JTO (Discs, Strips And Reagents, Microorganism Differentiation, 5); GQL (Antisera, Fluorescent, Herpesvirus Hominis 1,2, 1); GTZ (Antisera, All Groups, Streptococcus Spp., 1).
Next steps
- See all 16 Scott Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JTO, Scott Laboratories, 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, 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.