The following data is part of a premarket notification filed by Meridian Diagnostics, Inc. with the FDA for Endo-staph Teichoic Acid Antibody Kit.
| Device ID | K820531 |
| 510k Number | K820531 |
| Device Name: | ENDO-STAPH TEICHOIC ACID ANTIBODY KIT |
| Classification | Staphylococcus Aureus Somatic Antigens |
| Applicant | MERIDIAN DIAGNOSTICS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | LHT |
| CFR Regulation Number | 866.3700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-03-02 |
| Decision Date | 1982-04-14 |