The following data is part of a premarket notification filed by Quidel Corp. with the FDA for Quidel Group B Strep Test.
| Device ID | K896265 |
| 510k Number | K896265 |
| Device Name: | QUIDEL GROUP B STREP TEST |
| Classification | Antisera, All Groups, Streptococcus Spp. |
| Applicant | QUIDEL CORP. 10165 MCKELLAR COURT San Diego, CA 92121 |
| Contact | Robin Weiner |
| Correspondent | Robin Weiner QUIDEL CORP. 10165 MCKELLAR COURT San Diego, CA 92121 |
| Product Code | GTZ |
| CFR Regulation Number | 866.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-31 |
| Decision Date | 1990-02-16 |