The following data is part of a premarket notification filed by Bio-rad Laboratories, Inc. with the FDA for Access Troponin I Reagents On The Access Immunoassay Analyzer Model Numbers: 33320, 33325 And 33329.
| Device ID | K963934 |
| 510k Number | K963934 |
| Device Name: | ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBERS: 33320, 33325 AND 33329 |
| Classification | Immunoassay Method, Troponin Subunit |
| 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 | MMI |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-01 |
| Decision Date | 1996-12-16 |
| Summary: | summary |