The following data is part of a premarket notification filed by Carr-scarborough Microbiologicals, Inc. with the FDA for Ids Beta-lactamase Disc.
Device ID | K812047 |
510k Number | K812047 |
Device Name: | IDS BETA-LACTAMASE DISC |
Classification | Discs, Strips And Reagents, Microorganism Differentiation |
Applicant | CARR-SCARBOROUGH MICROBIOLOGICALS, 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 | 1981-07-20 |
Decision Date | 1981-08-07 |