The following data is part of a premarket notification filed by Miles Laboratories, Inc. with the FDA for Lab-tek Anacult Anaerobic Culture Chambe.
| Device ID | K800899 |
| 510k Number | K800899 |
| Device Name: | LAB-TEK ANACULT ANAEROBIC CULTURE CHAMBE |
| Classification | Device, Gas Generating |
| Applicant | MILES LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KZJ |
| CFR Regulation Number | 866.2580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-04-18 |
| Decision Date | 1980-05-23 |