The following data is part of a premarket notification filed by Chugai Pharmaceuticals Co., Ltd. with the FDA for Gen-probe Accuprobe Group B Streptococcus Culture Identification Test 2820.
| Device ID | K974572 |
| 510k Number | K974572 |
| Device Name: | GEN-PROBE ACCUPROBE GROUP B STREPTOCOCCUS CULTURE IDENTIFICATION TEST 2820 |
| Classification | Dna-probe, Reagents, Streptococcal |
| Applicant | CHUGAI PHARMACEUTICALS CO., LTD. 10210 GENETIC CENTER DR. San Diego, CA 92121 |
| Contact | Gerald H Schell |
| Correspondent | Gerald H Schell CHUGAI PHARMACEUTICALS CO., LTD. 10210 GENETIC CENTER DR. San Diego, CA 92121 |
| Product Code | MDK |
| CFR Regulation Number | 866.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-05 |
| Decision Date | 1998-09-24 |
| Summary: | summary |