The following data is part of a premarket notification filed by Laboratory Technologies, Inc. with the FDA for Acculyte Chemiluminescence Analyzer.
| Device ID | K921536 |
| 510k Number | K921536 |
| Device Name: | ACCULYTE CHEMILUMINESCENCE ANALYZER |
| Classification | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
| Applicant | LABORATORY TECHNOLOGIES, INC. 35 EAST IRVING PARK RD. Roselle, IL 60172 |
| Contact | Richard J Schmidt |
| Correspondent | Richard J Schmidt LABORATORY TECHNOLOGIES, INC. 35 EAST IRVING PARK RD. Roselle, IL 60172 |
| Product Code | JJQ |
| CFR Regulation Number | 862.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-11 |
| Decision Date | 1993-10-12 |