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 |