The following data is part of a premarket notification filed by Carr-scarborough Microbiologicals, Inc. with the FDA for Afb Stain Set.
Device ID | K812668 |
510k Number | K812668 |
Device Name: | AFB STAIN SET |
Classification | Stains, Microbiologic |
Applicant | CARR-SCARBOROUGH MICROBIOLOGICALS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JTS |
CFR Regulation Number | 864.1850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-09-21 |
Decision Date | 1981-09-29 |