The following data is part of a premarket notification filed by Ciba Corning Diagnostics Corp. with the FDA for Acs Lh2 Immunoassay.
| Device ID | K962041 |
| 510k Number | K962041 |
| Device Name: | ACS LH2 IMMUNOASSAY |
| Classification | Radioimmunoassay, Luteinizing Hormone |
| Applicant | CIBA CORNING DIAGNOSTICS CORP. 17392 DAIMLER ST. Irvine, CA 92714 |
| Contact | Thomas F Flynn |
| Correspondent | Thomas F Flynn CIBA CORNING DIAGNOSTICS CORP. 17392 DAIMLER ST. Irvine, CA 92714 |
| Product Code | CEP |
| CFR Regulation Number | 862.1485 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-28 |
| Decision Date | 1996-06-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414294094 | K962041 | 000 |
| 00630414504797 | K962041 | 000 |
| 00630414504773 | K962041 | 000 |
| 00630414504759 | K962041 | 000 |
| 00630414598314 | K962041 | 000 |
| 00630414598307 | K962041 | 000 |