The following data is part of a premarket notification filed by Analytical Products, Inc. with the FDA for Staph-ident.
Device ID | K811998 |
510k Number | K811998 |
Device Name: | STAPH-IDENT |
Classification | Discs, Strips And Reagents, Microorganism Differentiation |
Applicant | ANALYTICAL PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JTO |
CFR Regulation Number | 866.2660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-07-14 |
Decision Date | 1981-07-28 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
STAPH-IDENT 73346937 1266730 Dead/Cancelled |
American Home Products Corporation 1982-01-25 |