The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Access Toxoplasma Igm Reagents On The Access Immunoassay Analyzer, Models 34460, 34465, 34469.
Device ID | K973448 |
510k Number | K973448 |
Device Name: | ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 34460, 34465, 34469 |
Classification | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii |
Applicant | BECKMAN INSTRUMENTS, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
Contact | Michele Burtness |
Correspondent | Michele Burtness BECKMAN INSTRUMENTS, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
Product Code | LGD |
CFR Regulation Number | 866.3780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-09-11 |
Decision Date | 1998-09-17 |
Summary: | summary |