Medical Specialties Laboratories: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Medical Specialties Laboratories” (first 1981, latest 1985), across 5 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 |
|---|---|---|---|
| GGP | Test, Qualitative And Quantitative Factor Deficiency | 1 | 1 |
| GLQ | Mixture, Control, White-Cell And Red-Cell Indices | 1 | 1 |
| JPK | Mixture, Hematology Quality Control | 1 | 1 |
| KIS | Sera, Animal And Human | 1 | 1 |
Plus 1 more product codes.
Review panels
- Hematology (3)
- Pathology (1)
Most recent Medical Specialties Laboratories 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K852643 | UNI-PLATE | — | 1985-08-08 | 48 |
| K844897 | HEMATOLOGY CONTROL UNI-CELL 5, UNI-CELL 7 & 8 | JPK | 1985-03-22 | 95 |
| K840114 | COAGULATION FACTOR DEFICIENT PLASMA | GGP | 1984-02-04 | 24 |
| K823587 | UNI-CELL | GLQ | 1983-01-05 | 30 |
| K810268 | NORMLCERA | KIS | 1981-03-06 | 32 |
Recalls
openFDA lists no recalls under a recalling firm named Medical Specialties Laboratories.
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.
- Medical Analysis Systems, Inc. (107 510(k)s)
- Medical Components, Inc. (63 510(k)s)
- Medical Advances, Inc. (57 510(k)s)
- Medical Diagnostic Technologies, Inc. (57 510(k)s)
- Medical Devices, Inc. (49 510(k)s)
- Medical Device Technologies, Inc. (46 510(k)s)
- Medical Specialties, Inc. (40 510(k)s)
- Medical Device Inspection Co., Inc. (30 510(k)s)
- Medical Engineering Corp. (28 510(k)s)
- Medical Data Electronics (27 510(k)s)
- Medical Graphics Corp. (25 510(k)s)
- Medical Innovations Corp. (24 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medical Specialties Laboratories?
FDA lists 5 510(k) clearances under the applicant name “Medical Specialties Laboratories” (first 1981, latest 1985), across 5 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 Medical Specialties Laboratories?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medical Specialties Laboratories is 32 days.
Which FDA product codes appear under Medical Specialties Laboratories?
The most frequent FDA product codes under this applicant name are GGP (Test, Qualitative And Quantitative Factor Deficiency, 1); GLQ (Mixture, Control, White-Cell And Red-Cell Indices, 1); JPK (Mixture, Hematology Quality Control, 1).
Next steps
- See all 5 Medical Specialties Laboratories clearances with predicates and recalls
- Run predicate analysis for product code GGP, Medical Specialties Laboratories'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.