Submission Details
| 510(k) Number | K963286 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 21, 1996 |
| Decision Date | October 07, 1996 |
| Days to Decision | 47 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
Cleared
Traditional
IMMAGE IMMUNOCHEMISTRY SYSTEM HAPTOGLOBIN (HPT) REAGENT
Oct 1996
Decision
47d
Days
Class 2
Risk
About This 510(k) Submission
K963286 is an FDA 510(k) clearance for the IMMAGE IMMUNOCHEMISTRY SYSTEM HAPTOGLOBIN (HPT) REAGENT, a Haptoglobin, Antigen, Antiserum, Control (Class II — Special Controls, product code DAD), submitted by Beckman Instruments, Inc. (Brea, US). The FDA issued a Cleared decision on October 7, 1996, 47 days after receiving the submission on August 21, 1996. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5460.
Device Classification
| Product Code | DAD — Haptoglobin, Antigen, Antiserum, Control |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.5460 |
Manufacturer
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