The following data is part of a premarket notification filed by Ciba Corning Diagnostics Corp. with the FDA for Ciba Corning Acs Hcg Immunoassay.
| Device ID | K925277 |
| 510k Number | K925277 |
| Device Name: | CIBA CORNING ACS HCG IMMUNOASSAY |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | CIBA CORNING DIAGNOSTICS CORP. 333 CONEY ST. E. Walpole, MA 02032 |
| Contact | William J Pignato |
| Correspondent | William J Pignato CIBA CORNING DIAGNOSTICS CORP. 333 CONEY ST. E. Walpole, MA 02032 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-20 |
| Decision Date | 1993-03-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414505183 | K925277 | 000 |
| 00630414505176 | K925277 | 000 |
| 00630414505152 | K925277 | 000 |
| 00630414504742 | K925277 | 000 |
| 00630414197418 | K925277 | 000 |
| 00630414197401 | K925277 | 000 |
| 00630414190969 | K925277 | 000 |