The following data is part of a premarket notification filed by Ciba Corning Diagnostics Corp. with the FDA for Fertility Plus 1, 2, 3.
| Device ID | K935219 |
| 510k Number | K935219 |
| Device Name: | FERTILITY PLUS 1, 2, 3 |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | CIBA CORNING DIAGNOSTICS CORP. 490 SAN ANTONIO RD. Palo Alto, CA 94306 |
| Contact | Ronald D Schaefer |
| Correspondent | Ronald D Schaefer CIBA CORNING DIAGNOSTICS CORP. 490 SAN ANTONIO RD. Palo Alto, CA 94306 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-26 |
| Decision Date | 1994-03-22 |