The following data is part of a premarket notification filed by Cirrus Diagnostics, Inc. with the FDA for Immulite (tm) Automated Immunoassay Analyzer.
| Device ID | K905215 |
| 510k Number | K905215 |
| Device Name: | IMMULITE (TM) AUTOMATED IMMUNOASSAY ANALYZER |
| Classification | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
| Applicant | CIRRUS DIAGNOSTICS, INC. P.O BOX 15 Chester, NY 07930 |
| Contact | Robert Fennell |
| Correspondent | Robert Fennell CIRRUS DIAGNOSTICS, INC. P.O BOX 15 Chester, NY 07930 |
| Product Code | JJQ |
| CFR Regulation Number | 862.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-20 |
| Decision Date | 1991-01-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768028441 | K905215 | 000 |
| 00842768028434 | K905215 | 000 |
| 00842768028427 | K905215 | 000 |
| 00842768028410 | K905215 | 000 |
| 00630414965017 | K905215 | 000 |