Submission Details
| 510(k) Number | K974075 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 29, 1997 |
| Decision Date | November 10, 1997 |
| Days to Decision | 12 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
Nov 1997
Decision
12d
Days
Class 2
Risk
About This 510(k) Submission
K974075 is an FDA 510(k) clearance for the ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, a Immunoassay Method, Troponin Subunit (Class II — Special Controls, product code MMI), submitted by Beckman Instruments, Inc. (Chaska, US). The FDA issued a Cleared decision on November 10, 1997, 12 days after receiving the submission on October 29, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.
Device Classification
| Product Code | MMI — Immunoassay Method, Troponin Subunit |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1215 |
Manufacturer
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