The following data is part of a premarket notification filed by Chiron Diagnostics Corp. with the FDA for Certain Complete Levels 1,2, And 3; Cvm Levels 1,2,3,4, And 5.
| Device ID | K970956 |
| 510k Number | K970956 |
| Device Name: | CERTAIN COMPLETE LEVELS 1,2, AND 3; CVM LEVELS 1,2,3,4, AND 5 |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | CHIRON DIAGNOSTICS CORP. 63 NORTH ST. Medfield, MA 02052 |
| Contact | Thomas F Flynn |
| Correspondent | Thomas F Flynn CHIRON DIAGNOSTICS CORP. 63 NORTH ST. Medfield, MA 02052 |
| 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 | 1997-04-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414202174 | K970956 | 000 |
| 00630414202167 | K970956 | 000 |
| 00630414202150 | K970956 | 000 |
| 00630414195131 | K970956 | 000 |
| 00630414121802 | K970956 | 000 |
| 00630414121628 | K970956 | 000 |
| 00630414112985 | K970956 | 000 |