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 |