The following data is part of a premarket notification filed by Chiron Diagnostics Corp. with the FDA for Chiron Diagnostics Acs:180 Myoglobin.
| Device ID | K974325 |
| 510k Number | K974325 |
| Device Name: | CHIRON DIAGNOSTICS ACS:180 MYOGLOBIN |
| Classification | Myoglobin, Antigen, Antiserum, Control |
| Applicant | CHIRON DIAGNOSTICS CORP. 63 NORTH ST. Medfield, MA 02052 |
| Contact | William J Pignato |
| Correspondent | William J Pignato CHIRON DIAGNOSTICS CORP. 63 NORTH ST. Medfield, MA 02052 |
| Product Code | DDR |
| CFR Regulation Number | 866.5680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-18 |
| Decision Date | 1997-12-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414599687 | K974325 | 000 |
| 00630414599670 | K974325 | 000 |
| 00630414599663 | K974325 | 000 |
| 00630414598468 | K974325 | 000 |
| 00630414197197 | K974325 | 000 |
| 00630414197180 | K974325 | 000 |
| 00630414180014 | K974325 | 000 |
| 00630414178493 | K974325 | 000 |