The following data is part of a premarket notification filed by Medical Laboratory Automation Systems, Inc. with the FDA for Chlamydia Accu-culshure Tm.
| Device ID | K903405 |
| 510k Number | K903405 |
| Device Name: | CHLAMYDIA ACCU-CULSHURE TM |
| Classification | Device, Specimen Collection |
| 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 | LIO |
| CFR Regulation Number | 866.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-31 |
| Decision Date | 1990-10-16 |