The following data is part of a premarket notification filed by Ciba Corning Diagnostics Corp. with the FDA for Ciba Corning Acs;180 Dpd Assay.
| Device ID | K963251 |
| 510k Number | K963251 |
| Device Name: | CIBA CORNING ACS;180 DPD ASSAY |
| Classification | Column Chromatography & Color Development, Hydroxyproline |
| Applicant | CIBA CORNING DIAGNOSTICS CORP. 17392 DAIMLER ST. Irvine, CA 92714 |
| Contact | William J Pignato |
| Correspondent | William J Pignato CIBA CORNING DIAGNOSTICS CORP. 17392 DAIMLER ST. Irvine, CA 92714 |
| Product Code | JMM |
| CFR Regulation Number | 862.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-19 |
| Decision Date | 1996-10-15 |
| Summary: | summary |