The following data is part of a premarket notification filed by Integrated Computerized Laboratory Systems, Inc. with the FDA for I.c.l.s. Compulyzer.
| Device ID | K854055 |
| 510k Number | K854055 |
| Device Name: | I.C.L.S. COMPULYZER |
| Classification | Analyzer, Chemistry, Centrifugal, For Clinical Use |
| Applicant | INTEGRATED COMPUTERIZED LABORATORY SYSTEMS, INC. 3959 ELECTRIC RD., S.W. Roanoke, VA 24018 |
| Contact | Steven J Holt |
| Correspondent | Steven J Holt INTEGRATED COMPUTERIZED LABORATORY SYSTEMS, INC. 3959 ELECTRIC RD., S.W. Roanoke, VA 24018 |
| Product Code | JJG |
| CFR Regulation Number | 862.2140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-03 |
| Decision Date | 1985-11-19 |