The following data is part of a premarket notification filed by Ciba Corning Diagnostics Corp. with the FDA for Acs Ckmb Ii Immunoassay.
| Device ID | K962126 |
| 510k Number | K962126 |
| Device Name: | ACS CKMB II IMMUNOASSAY |
| Classification | Differential Rate Kinetic Method, Cpk Or Isoenzymes |
| Applicant | CIBA CORNING DIAGNOSTICS CORP. 17392 DAIMLER ST. Irvine, CA 92714 |
| Contact | Thomas F Flynn |
| Correspondent | Thomas F Flynn CIBA CORNING DIAGNOSTICS CORP. 17392 DAIMLER ST. Irvine, CA 92714 |
| Product Code | JHS |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-03 |
| Decision Date | 1996-06-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414598611 | K962126 | 000 |
| 00630414056098 | K962126 | 000 |
| 00630414124803 | K962126 | 000 |
| 00630414175324 | K962126 | 000 |
| 00630414177434 | K962126 | 000 |
| 00630414177441 | K962126 | 000 |
| 00630414598574 | K962126 | 000 |
| 00630414598581 | K962126 | 000 |
| 00630414598598 | K962126 | 000 |
| 00630414598604 | K962126 | 000 |
| 00630414294148 | K962126 | 000 |