Scientific Device Laboratory, Inc.: FDA filings under this applicant name
FDA lists 28 510(k) clearances under the applicant name “Scientific Device Laboratory, Inc.” (first 1984, latest 1994), across 12 product codes in 3 review panels. Median 510(k) review time under this name: 46 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 |
|---|---|---|---|
| LSC | Neisseria Controls | 7 | 7 |
| LJG | Quality Control Slides | 6 | 6 |
| GTY | Antigens, All Groups, Streptococcus Spp. | 3 | 3 |
| JTS | Stains, Microbiologic | 3 | 3 |
| JSJ | Culture Media, Selective And Non-Differential | 2 | 2 |
| FLE | Sterilizer, Steam | 1 | 1 |
| GGH | Iron Stains | 1 | 1 |
| GSI | Antigens, Slide And Tube, All Types, Listeria Monocytogenes | 1 | 1 |
| JSG | Culture Media, Non-Selective And Non-Differential | 1 | 1 |
| JTO | Discs, Strips And Reagents, Microorganism Differentiation | 1 | 1 |
Plus 2 more product codes.
Review panels
- Microbiology (26)
- General Hospital (1)
- Pathology (1)
Most recent Scientific Device Laboratory, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K935316 | PARASAFE(R) FIXATIVE | LKS | 1994-02-17 | 107 |
| K924893 | MICROSPORIDIUM CONTROL SLIDE | LJG | 1993-01-15 | 109 |
| K911059 | TURBIDOMETRIC STANDARD | LIE | 1991-06-10 | 91 |
| K895848 | PRESSURE STEAM STERILIZERS | FLE | 1989-12-11 | 69 |
| K890718 | GRAM STAIN CONTROL SLIDE | LJG | 1989-03-16 | 31 |
| K890670 | CRYPTOSPORIDIUM CONTROL SLIDE | LJG | 1989-03-16 | 35 |
| K884069 | SNAP N' STAIN IODINE STAIN | JTS | 1988-10-25 | 28 |
| K884011 | SNAP N' STAIN IRON STAIN | GGH | 1988-10-06 | 14 |
| K883052 | METHENO-STAIN KIT | JTS | 1988-08-30 | 42 |
| K881598 | SDL TRICHROME STAIN | JTS | 1988-05-04 | 21 |
18 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Scientific Device Laboratory, 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.
- Scientific Pharmaceuticals, Inc. (73 510(k)s)
- Scientific Sales Intl., Inc. (11 510(k)s)
- Scientific Distributors, Inc. (7 510(k)s)
- Scientific Device Manufacturer, LLC (6 510(k)s)
- Scientific Research (5 510(k)s)
- Scientific Imaging, Inc. (3 510(k)s)
- Scientific Specialties, Inc. (3 510(k)s)
- Scientific & General Pty. , Ltd. (2 510(k)s)
- Scientific Manufacturing Industries (2 510(k)s)
- Scientific Spinal , Ltd. (2 510(k)s)
- Scientific Standards, Inc. (2 510(k)s)
- Scientific Technology , Ltd. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Scientific Device Laboratory, Inc.?
FDA lists 28 510(k) clearances under the applicant name “Scientific Device Laboratory, Inc.” (first 1984, latest 1994), across 12 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 Scientific Device Laboratory, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Scientific Device Laboratory, Inc. is 46 days.
Which FDA product codes appear under Scientific Device Laboratory, Inc.?
The most frequent FDA product codes under this applicant name are LSC (Neisseria Controls, 7); LJG (Quality Control Slides, 6); GTY (Antigens, All Groups, Streptococcus Spp., 3).
Next steps
- See all 28 Scientific Device Laboratory, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LSC, Scientific Device Laboratory, 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.