The following data is part of a premarket notification filed by Medical Laboratory Automation Systems, Inc. with the FDA for Anaerobic Accu-culshure(tm).
| Device ID | K901645 |
| 510k Number | K901645 |
| Device Name: | ANAEROBIC ACCU-CULSHURE(TM) |
| Classification | Transport Systems, Anaerobic |
| Applicant | MEDICAL LABORATORY AUTOMATION SYSTEMS, INC. 270 MARBLE AVE. Pleasantville, NY 10570 |
| Contact | Joann Hanchrow |
| Correspondent | Joann Hanchrow MEDICAL LABORATORY AUTOMATION SYSTEMS, INC. 270 MARBLE AVE. Pleasantville, NY 10570 |
| Product Code | JTX |
| CFR Regulation Number | 866.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-09 |
| Decision Date | 1990-07-16 |