The following data is part of a premarket notification filed by Medix Biotech, Inc. with the FDA for Medix Biotech Strep A Antigen Detection Test (modification).
| Device ID | K952873 |
| 510k Number | K952873 |
| Device Name: | MEDIX BIOTECH STREP A ANTIGEN DETECTION TEST (MODIFICATION) |
| Classification | Antisera, All Groups, Streptococcus Spp. |
| Applicant | MEDIX BIOTECH, INC. 1531 INDUSTRIAL RD. San Carlos, CA 94070 |
| Contact | Delia R Bethell |
| Correspondent | Delia R Bethell MEDIX BIOTECH, INC. 1531 INDUSTRIAL RD. San Carlos, CA 94070 |
| Product Code | GTZ |
| CFR Regulation Number | 866.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-06 |
| Decision Date | 1995-09-08 |