The following data is part of a premarket notification filed by Gen-probe, Inc. with the FDA for Gen-probe Direct Group A Streptococus Test.
| Device ID | K924715 |
| 510k Number | K924715 |
| Device Name: | GEN-PROBE DIRECT GROUP A STREPTOCOCUS TEST |
| Classification | Dna-probe, Reagents, Streptococcal |
| Applicant | GEN-PROBE, INC. 9880 CAMPUS POINT DR. San Diego, CA 92121 |
| Contact | Ruben Chairez |
| Correspondent | Ruben Chairez GEN-PROBE, INC. 9880 CAMPUS POINT 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 | 1992-09-21 |
| Decision Date | 1994-03-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15420045506312 | K924715 | 000 |
| 15420045506305 | K924715 | 000 |