Submission Details
| 510(k) Number | K974564 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 05, 1997 |
| Decision Date | February 17, 1998 |
| Days to Decision | 74 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
Cleared
Traditional
IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-2-MACROGLOBULIN REAGENT
Feb 1998
Decision
74d
Days
Class 2
Risk
About This 510(k) Submission
K974564 is an FDA 510(k) clearance for the IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-2-MACROGLOBULIN REAGENT, a Alpha-2-macroglobulin, Antigen, Antiserum, Control (Class II — Special Controls, product code DEB), submitted by Beckman Instruments, Inc. (Brea, US). The FDA issued a Cleared decision on February 17, 1998, 74 days after receiving the submission on December 5, 1997. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5620.
Device Classification
| Product Code | DEB — Alpha-2-macroglobulin, Antigen, Antiserum, Control |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.5620 |
Manufacturer
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