The following data is part of a premarket notification filed by Dpc Cirrus with the FDA for Immulite 2000 Automated Immunoassay Analyzer.
| Device ID | K970227 |
| 510k Number | K970227 |
| Device Name: | IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZER |
| Classification | Analyzer, Chemistry (photometric, Discrete), For Clinical Use |
| Applicant | DPC CIRRUS 111 CANFIELD AVE., B15 Randolph, NJ 07869 -1114 |
| Contact | Robert M Di Tullio |
| Correspondent | Robert M Di Tullio DPC CIRRUS 111 CANFIELD AVE., B15 Randolph, NJ 07869 -1114 |
| Product Code | JJE |
| Subsequent Product Code | CGJ |
| Subsequent Product Code | DHB |
| Subsequent Product Code | JHR |
| Subsequent Product Code | JLW |
| Subsequent Product Code | KLS |
| CFR Regulation Number | 862.2160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-17 |
| Decision Date | 1997-04-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414982410 | K970227 | 000 |
| 00630414965741 | K970227 | 000 |
| 00630414595177 | K970227 | 000 |
| 00630414945422 | K970227 | 000 |
| 00630414961828 | K970227 | 000 |
| 00630414962160 | K970227 | 000 |
| 00630414962184 | K970227 | 000 |
| 00630414962351 | K970227 | 000 |
| 00630414982403 | K970227 | 000 |
| 00630414965734 | K970227 | 000 |