Streck Laboratories, Inc.: FDA clearances and approvals
Streck Laboratories, Inc. has 70 FDA 510(k) clearances (first 1977, latest 2004), across 21 product codes in 3 review panels. Median 510(k) review time: 49 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 |
|---|---|---|---|
| JPK | Mixture, Hematology Quality Control | 23 | 23 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 9 | 9 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 7 | 7 |
| GGL | Control, White-Cell | 4 | 4 |
| GLQ | Mixture, Control, White-Cell And Red-Cell Indices | 4 | 4 |
| JCN | Control, Cell Counter, Normal And Abnormal | 4 | 4 |
| GHM | Test, Sickle Cell | 2 | 2 |
| GJR | Control, Red-Cell | 2 | 2 |
| KRX | Calibrator For Cell Indices | 2 | 2 |
| KRY | Calibrator For Platelet Counting | 2 | 2 |
Plus 11 more product codes.
Review panels
- Hematology (49)
- Clinical Chemistry (19)
- Clinical Toxicology (1)
Most recent Streck Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K042587 | RETIC-CHEX FOR CELL-DYN | JPK | 2004-10-19 | 27 |
| K040107 | CYTO-CHEX BCT | JKA | 2004-07-27 | 189 |
| K040025 | A1C-CELLULAR | JJX | 2004-03-02 | 55 |
| K023656 | SICKLE-CHEX SOLUBILITY KIT | GHM | 2002-12-30 | 61 |
| K021922 | MODIFICATION TO PARA 5X | JPK | 2002-06-25 | 14 |
| K020469 | CAL-CHEX CD PLUS | KRX | 2002-04-04 | 51 |
| K013316 | SICKLE-CHEX | GHM | 2001-11-06 | 33 |
| K011410 | PARA 5X | JPK | 2001-06-26 | 49 |
| K001443 | SUGAR CHEX ONE | JJX | 2000-06-29 | 52 |
| K000945 | PARA 12 PLUS RETICS | GLQ | 2000-04-18 | 26 |
60 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Streck 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.
Frequently asked questions
How many FDA 510(k) clearances does Streck Laboratories, Inc. have?
Streck Laboratories, Inc. has 70 FDA 510(k) clearances (first 1977, latest 2004), across 21 product codes in 3 review panels.
How long does FDA take to clear Streck Laboratories, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Streck Laboratories, Inc.'s cleared 510(k)s is 49 days.
What devices does Streck Laboratories, Inc. make?
Its most frequent FDA product codes are JPK (Mixture, Hematology Quality Control, 23); JJX (Single (Specified) Analyte Controls (Assayed And Unassayed), 9); JJY (Multi-Analyte Controls, All Kinds (Assayed), 7).
Has Streck Laboratories, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Streck Laboratories, Inc. Related entities may recall under other names.
Next steps
- See all 70 Streck Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JPK, Streck 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.