MDK
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Dna-Probe, Reagents, Streptococcal
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3740
- Medical specialty
- Microbiology
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| GEN-PROBE ACCUPROBE GROUP B STREPTOCOCCUS CULTURE IDENTIFICATION TEST 2820 (K974572) | Chugai Pharmaceuticals Co., Ltd. | 1998-09-24 |
| GEN-PROBE DIRECT GROUP A STREPTOCOCUS TEST (K924715) | Gen-Probe, Inc. | 1994-03-11 |
| ACCUPACE GROUP A STREPTOCOCCUS ID TEST (K915852) | Gen-Probe, Inc. | 1992-04-02 |
| ACCUPROBE STREPTOCOCCUS PYOGENES CULTURE CONFIRM. (K904268) | Gen-Probe, Inc. | 1990-11-13 |
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Every clearance here is in the API, with alerts when new ones post.