Submission Details
| 510(k) Number | K973813 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 07, 1997 |
| Decision Date | November 20, 1997 |
| Days to Decision | 44 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
Cleared
Traditional
IMMUNOCHEMISTRY SYSTEM BETA-2-MICROGLOBULIN REAGENT
Nov 1997
Decision
44d
Days
Class 2
Risk
About This 510(k) Submission
K973813 is an FDA 510(k) clearance for the IMMUNOCHEMISTRY SYSTEM BETA-2-MICROGLOBULIN REAGENT, a System, Test, Beta-2-microglobulin Immunological (Class II — Special Controls, product code JZG), submitted by Beckman Instruments, Inc. (Brea, US). The FDA issued a Cleared decision on November 20, 1997, 44 days after receiving the submission on October 7, 1997. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5630.
Device Classification
| Product Code | JZG — System, Test, Beta-2-microglobulin Immunological |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.5630 |
Manufacturer
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