Submission Details
| 510(k) Number | K973448 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 11, 1997 |
| Decision Date | September 17, 1998 |
| Days to Decision | 371 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
Cleared
Traditional
ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 34460, 34465, 34469
Sep 1998
Decision
371d
Days
Class 2
Risk
About This 510(k) Submission
K973448 is an FDA 510(k) clearance for the ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 34460, 34465, 34469, a Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (Class II — Special Controls, product code LGD), submitted by Beckman Instruments, Inc. (Chaska, US). The FDA issued a Cleared decision on September 17, 1998, 371 days after receiving the submission on September 11, 1997. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3780.
Device Classification
| Product Code | LGD — Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.3780 |
Manufacturer
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