The following data is part of a premarket notification filed by Syntron Bioresearch, Inc. with the FDA for Quikpac Strep A Test.
| Device ID | K924007 |
| 510k Number | K924007 |
| Device Name: | QUIKPAC STREP A TEST |
| Classification | Antisera, All Groups, Streptococcus Spp. |
| Applicant | SYNTRON BIORESEARCH, INC. 1080 JOSHUA WAY Vista, CA 92083 |
| Contact | Benedict Zin |
| Correspondent | Benedict Zin SYNTRON BIORESEARCH, INC. 1080 JOSHUA WAY Vista, CA 92083 |
| Product Code | GTZ |
| CFR Regulation Number | 866.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-10 |
| Decision Date | 1993-04-06 |