The following data is part of a premarket notification filed by Carr-scarborough Microbiologicals, Inc. with the FDA for Pyr Broth.
Device ID | K820149 |
510k Number | K820149 |
Device Name: | PYR BROTH |
Classification | Culture Media, Single Biochemical Test |
Applicant | CARR-SCARBOROUGH MICROBIOLOGICALS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JSF |
CFR Regulation Number | 866.2320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-01-19 |
Decision Date | 1982-02-05 |