The following data is part of a premarket notification filed by Carr-scarborough Microbiologicals, Inc. with the FDA for Auramine O Mycrobacterial Stain Set.
| Device ID | K812274 |
| 510k Number | K812274 |
| Device Name: | AURAMINE O MYCROBACTERIAL STAIN SET |
| Classification | Auramine O |
| Applicant | CARR-SCARBOROUGH MICROBIOLOGICALS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KJK |
| CFR Regulation Number | 864.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-08-13 |
| Decision Date | 1981-09-01 |