The following data is part of a premarket notification filed by Cirrus Diagnostics, Inc. with the FDA for Immulite(tm) Hcg.
| Device ID | K911796 |
| 510k Number | K911796 |
| Device Name: | IMMULITE(TM) HCG |
| Classification | System, Test, Human Chorionic Gonadotropin |
| Applicant | CIRRUS DIAGNOSTICS, INC. P.O. BOX 15 Chester, NJ 07930 |
| Contact | Robert Fennell |
| Correspondent | Robert Fennell CIRRUS DIAGNOSTICS, INC. P.O. BOX 15 Chester, NJ 07930 |
| Product Code | DHA |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-22 |
| Decision Date | 1991-06-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414963716 | K911796 | 000 |
| 00630414960920 | K911796 | 000 |
| 00630414953205 | K911796 | 000 |