Kent Laboratories, Inc.: FDA clearances and approvals
Kent Laboratories, Inc. has 40 FDA 510(k) clearances (first 1977, latest 1995), across 28 product codes in 3 review panels. Median 510(k) review time: 50 days.
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 |
|---|---|---|---|
| DEW | Igg, Antigen, Antiserum, Control | 5 | 5 |
| DDB | Ceruloplasmin, Antigen, Antiserum, Control | 3 | 3 |
| DFK | Igg (Fab Fragment Specific), Antigen, Antiserum, Control | 3 | 3 |
| DAS | Igg (Fc Fragment Specific), Antigen, Antiserum, Control | 2 | 2 |
| DFZ | Igg (Gamma Chain Specific), Antigen, Antiserum, Control | 2 | 2 |
| JZJ | Prealbumin, Antigen, Antiserum, Control | 2 | 2 |
| MSJ | Apolipoproteins | 2 | 2 |
| CZJ | Igd, Antigen, Antiserum, Control | 1 | 1 |
| CZP | Iga, Antigen, Antiserum, Control | 1 | 1 |
| CZX | Hemopexin, Antigen, Antiserum, Control | 1 | 1 |
Plus 18 more product codes.
Review panels
- Immunology (37)
- Clinical Chemistry (2)
- Hematology (1)
Most recent Kent Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K951966 | HUMAN PREALBUMIN RADIAL IMMUNODIFFUSION KIT | JZJ | 1995-06-01 | 35 |
| K951968 | HUMAN C1Q RADIAL IMMUNODIFFUSION KIT | DAK | 1995-05-30 | 33 |
| K951967 | HUMAN C1 INACTIVATOR OR C-1 ESTERASE INHIBITOR RADIAL IMMUNODIFFUSION KIT | DBA | 1995-05-30 | 33 |
| K950102 | HUMAN C-5 RADIAL IMMUNODIFFUSION KIT | DAY | 1995-04-10 | 89 |
| K850683 | 72 DETERM. SIZE RADIAL IMMUNODIFFUSION TEST ALPHA2 | DEB | 1985-11-27 | 279 |
| K850682 | 72 DETERM. SIZE RADIAL IMMUNO. TEST HUMAN CERULOPL | DDB | 1985-11-25 | 277 |
| K850691 | ANTISERUM TO HUMAN APOLIPOPROTEIN A-I | MSJ | 1985-11-01 | 253 |
| K850690 | ANTISERUM TO HUMAN APOLIPOPROTEIN B | MSJ | 1985-11-01 | 253 |
| K850686 | ANTISERUM TO HUMAN PREALBUMIN | JZJ | 1985-11-01 | 253 |
| K831961 | IMMUNODIFFUSION TEST HUMAN ANTITHROMBIN | JBQ | 1983-08-11 | 55 |
30 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Kent Laboratories, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Kent Laboratories, Inc.'s product codes (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances does Kent Laboratories, Inc. have?
Kent Laboratories, Inc. has 40 FDA 510(k) clearances (first 1977, latest 1995), across 28 product codes in 3 review panels.
How long does FDA take to clear Kent Laboratories, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Kent Laboratories, Inc.'s cleared 510(k)s is 50 days.
What devices does Kent Laboratories, Inc. make?
Its most frequent FDA product codes are DEW (Igg, Antigen, Antiserum, Control, 5); DDB (Ceruloplasmin, Antigen, Antiserum, Control, 3); DFK (Igg (Fab Fragment Specific), Antigen, Antiserum, Control, 3).
Has Kent Laboratories, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Kent Laboratories, Inc. Related entities may recall under other names.
Next steps
- See all 40 Kent Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DEW, Kent Laboratories, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.