The following data is part of a premarket notification filed by Medix Biotech, Inc. with the FDA for Medix Biotech Bestest Strep A Cat. No. Bsf1010.
| Device ID | K932482 |
| 510k Number | K932482 |
| Device Name: | MEDIX BIOTECH BESTEST STREP A CAT. NO. BSF1010 |
| Classification | Antisera, All Groups, Streptococcus Spp. |
| Applicant | MEDIX BIOTECH, INC. 420 LINCOLN CENTRE DR. Foster City, CA 94404 |
| Contact | John Chen |
| Correspondent | John Chen MEDIX BIOTECH, INC. 420 LINCOLN CENTRE DR. Foster City, CA 94404 |
| Product Code | GTZ |
| CFR Regulation Number | 866.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-24 |
| Decision Date | 1994-07-18 |