The following data is part of a premarket notification filed by Innovative Medical Systems, Inc. with the FDA for Labotech Automated Microtiter Analyzer.
| Device ID | K922081 |
| 510k Number | K922081 |
| Device Name: | LABOTECH AUTOMATED MICROTITER ANALYZER |
| Classification | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
| Applicant | INNOVATIVE MEDICAL SYSTEMS, INC. P.O. BOX 4450 Warren, NJ 07060 |
| Contact | Ray Anderson |
| Correspondent | Ray Anderson INNOVATIVE MEDICAL SYSTEMS, INC. P.O. BOX 4450 Warren, NJ 07060 |
| Product Code | JJQ |
| CFR Regulation Number | 862.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-05 |
| Decision Date | 1992-09-02 |