The following data is part of a premarket notification filed by Austin Biological Laboratories with the FDA for Anaerobe Kit.
| Device ID | K850052 |
| 510k Number | K850052 |
| Device Name: | ANAEROBE KIT |
| Classification | Kit, Anaerobic Identification |
| Applicant | AUSTIN BIOLOGICAL LABORATORIES 6620-A MANOR RD. Austin, TX 78723 |
| Contact | Ray Schneider |
| Correspondent | Ray Schneider AUSTIN BIOLOGICAL LABORATORIES 6620-A MANOR RD. Austin, TX 78723 |
| Product Code | JSP |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-08 |
| Decision Date | 1985-03-05 |