Streck: FDA filings under this applicant name
FDA lists 35 510(k) clearances under 2 spellings of the applicant name “Streck” (first 2005, latest 2026), plus 1 De Novo decision, across 9 product codes in 3 review panels. Median 510(k) review time under this name: 140 days. Since 2017 the median was 90 days, against 90 days for all cleared 510(k)s in the same product codes. 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 | 4 | 221 |
| 2013 | 0 | — |
| 2014 | 5 | 140 |
| 2015 | 0 | — |
| 2016 | 4 | 296 |
| 2017 | 1 | 30 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 156 |
| 2023 | 2 | 90 |
| 2024 | 1 | 406 |
| 2025 | 0 | — |
| 2026 | 1 | 90 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Streck took a median 90 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 90 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JPK | Mixture, Hematology Quality Control | 12 | 12 |
| KRX | Calibrator For Cell Indices | 7 | 7 |
| GLQ | Mixture, Control, White-Cell And Red-Cell Indices | 4 | 4 |
| PMN | Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays | 4 | 4 |
| GGL | Control, White-Cell | 2 | 2 |
| GJR | Control, Red-Cell | 2 | 2 |
| JJW | Urinalysis Controls (Assayed And Unassayed) | 2 | 2 |
| QMA | Blood Collection Device For Cell-Free Nucleic Acid | 2 | 1 |
| GIM | Tubes, Vacuum Sample, With Anticoagulant | 1 | 1 |
Review panels
- Hematology (27)
- Clinical Chemistry (5)
- Microbiology (4)
Most recent Streck 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K254166 | MDx-Chex for BCN | PMN | 2026-03-23 | 90 |
| K231776 | Cell-Free DNA BCT | QMA | 2024-07-26 | 406 |
| K231223 | MDx-Chex for BC-GN | PMN | 2023-07-27 | 90 |
| K231221 | MDx-Chex for BC-GP | PMN | 2023-07-27 | 90 |
| K212576 | MDx-Chex for BCID2 | PMN | 2022-01-19 | 156 |
| K170091 | UA-Cellular Complete | JJW | 2017-02-09 | 30 |
| K160590 | XN CHECK | JPK | 2016-12-22 | 296 |
| K160588 | XN CHECK BF | JPK | 2016-12-22 | 296 |
| K160586 | XN-L CHECK | JPK | 2016-12-22 | 296 |
| K160585 | XN CAL | KRX | 2016-12-22 | 296 |
25 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN200001 | De Novo | Blood Collection Device For Cell-Free Nucleic Acid | 2020-08-07 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2017-02-23.
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.
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Streck (33)
- Streck, Inc. (3)
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.
- Streck Laboratories, Inc. (70 510(k)s)
- Streck, LLC (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Streck?
FDA lists 35 510(k) clearances under 2 spellings of the applicant name “Streck” (first 2005, latest 2026), plus 1 De Novo decision, across 9 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 Streck?
The median time from FDA receipt to decision across 510(k)s cleared under the name Streck is 140 days. Since 2017: 90 days, versus 90 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Streck?
The most frequent FDA product codes under this applicant name are JPK (Mixture, Hematology Quality Control, 12); KRX (Calibrator For Cell Indices, 7); GLQ (Mixture, Control, White-Cell And Red-Cell Indices, 4).
Next steps
- See all 35 Streck clearances with predicates and recalls
- Run predicate analysis for product code JPK, Streck'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.