Panels › Microbiology › Product code MDK · Class 1
Dna-Probe, Reagents, Streptococcal
Regulation 866.3740
0510(k)s in 12 months (4 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in MDK
| Company | 510(k)s | Recalls |
|---|---|---|
| Gen-Probe, Inc. | 3 | 2 |
| Chugai Pharmaceuticals Co., Ltd. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 24, 1998 | K974572 | GEN-PROBE ACCUPROBE GROUP B STREPTOCOCCUS CULTURE IDENTIFICATION TEST 2820 Chugai Pharmaceuticals Co., Ltd. | MDK |
| Mar 11, 1994 | K924715 | GEN-PROBE DIRECT GROUP A STREPTOCOCUS TEST Gen-Probe, Inc. | MDK |
| Apr 2, 1992 | K915852 | ACCUPACE GROUP A STREPTOCOCCUS ID TEST Gen-Probe, Inc. | MDK |
| Nov 13, 1990 | K904268 | ACCUPROBE STREPTOCOCCUS PYOGENES CULTURE CONFIRM. Gen-Probe, Inc. | MDK |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.