The following data is part of a premarket notification filed by Analytical Products, Inc. with the FDA for Salmonella I.d..
Device ID | K821338 |
510k Number | K821338 |
Device Name: | SALMONELLA I.D. |
Classification | Antisera, All Groups, Salmonella Spp. |
Applicant | ANALYTICAL PRODUCTS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | GRM |
CFR Regulation Number | 866.3550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-05-05 |
Decision Date | 1982-05-28 |