The following data is part of a premarket notification filed by Austin Biological Laboratories with the FDA for Lyophilized Microorganisms.
| Device ID | K831653 |
| 510k Number | K831653 |
| Device Name: | LYOPHILIZED MICROORGANISMS |
| Classification | Kit, Quality Control For Culture Media |
| Applicant | AUSTIN BIOLOGICAL LABORATORIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JTR |
| CFR Regulation Number | 866.2480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-05-23 |
| Decision Date | 1983-07-28 |