The following data is part of a premarket notification filed by Cirrus Diagnostics, Inc. with the FDA for Immulite(r) Fsh.
| Device ID | K921704 |
| 510k Number | K921704 |
| Device Name: | IMMULITE(R) FSH |
| Classification | Radioimmunoassay, Follicle-stimulating 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 | CGJ |
| CFR Regulation Number | 862.1300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-10 |
| Decision Date | 1992-06-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414964010 | K921704 | 000 |
| 00630414953779 | K921704 | 000 |