The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Access Troponin I Reagents On The Access Immunoassay Analyzer.
Device ID | K974075 |
510k Number | K974075 |
Device Name: | ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER |
Classification | Immunoassay Method, Troponin Subunit |
Applicant | BECKMAN INSTRUMENTS, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
Contact | Jan Olsen |
Correspondent | Jan Olsen BECKMAN INSTRUMENTS, 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 | 1997-10-29 |
Decision Date | 1997-11-10 |
Summary: | summary |