The following data is part of a premarket notification filed by Remel Co. with the FDA for Pyr Broth.
Device ID | K843987 |
510k Number | K843987 |
Device Name: | PYR BROTH |
Classification | Discs, Strips And Reagents, Microorganism Differentiation |
Applicant | REMEL CO. 12076 SANTA FE DR. Lenexa, KS 66215 |
Contact | James G Baxendale |
Correspondent | James G Baxendale REMEL CO. 12076 SANTA FE DR. Lenexa, KS 66215 |
Product Code | JTO |
CFR Regulation Number | 866.2660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-10-11 |
Decision Date | 1984-10-30 |