The following data is part of a premarket notification filed by Medix Biotech, Inc. with the FDA for Sure-strep A Test Kit Catalog No. Mb-1083.
| Device ID | K872346 |
| 510k Number | K872346 |
| Device Name: | SURE-STREP A TEST KIT CATALOG NO. MB-1083 |
| Classification | Antisera, All Groups, Streptococcus Spp. |
| Applicant | MEDIX BIOTECH, INC. 420 LINCOLN CENTRE DR. Foster City, CA 94404 |
| Contact | John J Huang |
| Correspondent | John J Huang 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 | 1987-06-17 |
| Decision Date | 1987-09-30 |