The following data is part of a premarket notification filed by Austin Biological Laboratories with the FDA for Austin Nonfermenter Kit.
| Device ID | K870769 |
| 510k Number | K870769 |
| Device Name: | AUSTIN NONFERMENTER KIT |
| Classification | Kit, Identification, Glucose Nonfermenter |
| Applicant | AUSTIN BIOLOGICAL LABORATORIES 6620-A MANOR RD. Austin, TX 78723 |
| Contact | Dennis Schneider,phd |
| Correspondent | Dennis Schneider,phd AUSTIN BIOLOGICAL LABORATORIES 6620-A MANOR RD. Austin, TX 78723 |
| Product Code | JSW |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-02-26 |
| Decision Date | 1987-04-03 |