The following data is part of a premarket notification filed by Whittaker Bioproducts, Inc. with the FDA for Toxostat M Test Kit.
| Device ID | K875113 |
| 510k Number | K875113 |
| Device Name: | TOXOSTAT M TEST KIT |
| Classification | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii |
| Applicant | WHITTAKER BIOPRODUCTS, INC. 8830 BRIGG FORD RD. Walkersville, MD 21793 |
| Contact | Marie P Reeves |
| Correspondent | Marie P Reeves WHITTAKER BIOPRODUCTS, INC. 8830 BRIGG FORD RD. Walkersville, MD 21793 |
| Product Code | LGD |
| CFR Regulation Number | 866.3780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-15 |
| Decision Date | 1988-04-12 |