The following data is part of a premarket notification filed by Chiron Diagnostics Corp. with the FDA for Liquid Csf(lcr)1, Liquid Csf(lcr)2.
| Device ID | K970979 |
| 510k Number | K970979 |
| Device Name: | LIQUID CSF(LCR)1, LIQUID CSF(LCR)2 |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | CHIRON DIAGNOSTICS CORP. 17392 DAIMLER ST. Irvine, CA 92614 |
| Contact | Ronald D Schaefer |
| Correspondent | Ronald D Schaefer CHIRON DIAGNOSTICS CORP. 17392 DAIMLER ST. Irvine, CA 92614 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-17 |
| Decision Date | 1997-04-02 |