Submission Details
| 510(k) Number | K963974 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 02, 1996 |
| Decision Date | March 06, 1997 |
| Days to Decision | 155 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
Cleared
Traditional
IMAGE-IMMUNOCHEMISTRY SYSTEM URINE IMMUNOGLOBULIN
Mar 1997
Decision
155d
Days
Class 2
Risk
About This 510(k) Submission
K963974 is an FDA 510(k) clearance for the IMAGE-IMMUNOCHEMISTRY SYSTEM URINE IMMUNOGLOBULIN, a Igg, Antigen, Antiserum, Control (Class II — Special Controls, product code DEW), submitted by Beckman Instruments, Inc. (Brea, US). The FDA issued a Cleared decision on March 6, 1997, 155 days after receiving the submission on October 2, 1996. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.
Device Classification
| Product Code | DEW — Igg, Antigen, Antiserum, Control |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.5510 |
Manufacturer
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