Submission Details
| 510(k) Number | K964257 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 25, 1996 |
| Decision Date | March 24, 1997 |
| Days to Decision | 150 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
Cleared
Traditional
IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ACID GLYCOPROTEIN (AAG) REAGENT
Mar 1997
Decision
150d
Days
Class 1
Risk
About This 510(k) Submission
K964257 is an FDA 510(k) clearance for the IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ACID GLYCOPROTEIN (AAG) REAGENT, a Alpha-1-acid-glycoprotein, Antigen, Antiserum, Control (Class I — General Controls, product code LKL), submitted by Beckman Instruments, Inc. (Brea, US). The FDA issued a Cleared decision on March 24, 1997, 150 days after receiving the submission on October 25, 1996. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5420.
Device Classification
| Product Code | LKL — Alpha-1-acid-glycoprotein, Antigen, Antiserum, Control |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 866.5420 |
Manufacturer
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