The following data is part of a premarket notification filed by Bio-rad Laboratories, Inc. with the FDA for Access Ck-mb Reagents.
| Device ID | K945083 |
| 510k Number | K945083 |
| Device Name: | ACCESS CK-MB REAGENTS |
| Classification | Differential Rate Kinetic Method, Cpk Or Isoenzymes |
| Applicant | BIO-RAD LABORATORIES, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Contact | Jan Olsen |
| Correspondent | Jan Olsen BIO-RAD LABORATORIES, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Product Code | JHS |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-17 |
| Decision Date | 1994-11-21 |