The following data is part of a premarket notification filed by Cirrus Diagnostics, Inc. with the FDA for Immulite Hlh.
| Device ID | K920411 |
| 510k Number | K920411 |
| Device Name: | IMMULITE HLH |
| Classification | Radioimmunoassay, Luteinizing Hormone |
| Applicant | CIRRUS DIAGNOSTICS, INC. P.O. BOX 15 Chester, NJ 07930 |
| Contact | Di Tullio |
| Correspondent | Di Tullio CIRRUS DIAGNOSTICS, INC. P.O. BOX 15 Chester, NJ 07930 |
| Product Code | CEP |
| CFR Regulation Number | 862.1485 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-31 |
| Decision Date | 1992-03-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414961699 | K920411 | 000 |
| 00630414964225 | K920411 | 000 |
| 00630414961705 | K920411 | 000 |
| 00630414167480 | K920411 | 000 |
| 00630414167459 | K920411 | 000 |