The following data is part of a premarket notification filed by Ciba Corning Diagnostics Corp. with the FDA for Ciba Corning Acs Progesterone Immunoassay.
| Device ID | K932955 |
| 510k Number | K932955 |
| Device Name: | CIBA CORNING ACS PROGESTERONE IMMUNOASSAY |
| Classification | Radioimmunoassay, Progesterone |
| Applicant | CIBA CORNING DIAGNOSTICS CORP. 333 CONEY ST. E. Walpole, MA 02032 |
| Contact | William Pignato |
| Correspondent | William Pignato CIBA CORNING DIAGNOSTICS CORP. 333 CONEY ST. E. Walpole, MA 02032 |
| Product Code | JLS |
| CFR Regulation Number | 862.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-17 |
| Decision Date | 1993-08-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414598406 | K932955 | 000 |
| 00630414454528 | K932955 | 000 |
| 00630414454641 | K932955 | 000 |
| 00630414599779 | K932955 | 000 |
| 00630414599786 | K932955 | 000 |
| 00630414599793 | K932955 | 000 |
| 00630414603070 | K932955 | 000 |
| 00630414294124 | K932955 | 000 |
| 00630414294216 | K932955 | 000 |
| 00630414524719 | K932955 | 000 |
| 00630414524726 | K932955 | 000 |
| 00630414524733 | K932955 | 000 |
| 00630414598390 | K932955 | 000 |
| 00630414204147 | K932955 | 000 |