The following data is part of a premarket notification filed by Pacific Biotech, Inc. with the FDA for Strep A Negative Control.
| Device ID | K924461 |
| 510k Number | K924461 |
| Device Name: | STREP A NEGATIVE CONTROL |
| Classification | Antisera, All Groups, Streptococcus Spp. |
| Applicant | PACIFIC BIOTECH, INC. 9050 CAMINO SANTA FE San Diego, CA 92121 |
| Contact | Connie Kirby |
| Correspondent | Connie Kirby PACIFIC BIOTECH, INC. 9050 CAMINO SANTA FE 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 | 1992-09-02 |
| Decision Date | 1993-12-02 |