The following data is part of a premarket notification filed by Bio-chem Laboratory Systems, Inc. with the FDA for Atac 8000 Random Access Chemistry System.
| Device ID | K945271 |
| 510k Number | K945271 |
| Device Name: | ATAC 8000 RANDOM ACCESS CHEMISTRY SYSTEM |
| Classification | Analyzer, Chemistry (photometric, Discrete), For Clinical Use |
| Applicant | BIO-CHEM LABORATORY SYSTEMS, INC. 195 LEHIGH AVE. Lakewood, NJ 08701 |
| Contact | Jon D Turpen |
| Correspondent | Jon D Turpen BIO-CHEM LABORATORY SYSTEMS, INC. 195 LEHIGH AVE. Lakewood, NJ 08701 |
| Product Code | JJE |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CGZ |
| Subsequent Product Code | CHH |
| Subsequent Product Code | CHL |
| Subsequent Product Code | JGS |
| CFR Regulation Number | 862.2160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-18 |
| Decision Date | 1995-04-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03661540304187 | K945271 | 000 |
| 03661540304170 | K945271 | 000 |
| 03661540304163 | K945271 | 000 |
| 03661540304156 | K945271 | 000 |