Submission Details
| 510(k) Number | K981403 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 17, 1998 |
| Decision Date | May 08, 1998 |
| Days to Decision | 21 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
Cleared
Traditional
IMMAGE IMMUNOCHEMISTRY SYSTEM VALPROIC ACID (VPA) REAGENT
May 1998
Decision
21d
Days
Class 2
Risk
About This 510(k) Submission
K981403 is an FDA 510(k) clearance for the IMMAGE IMMUNOCHEMISTRY SYSTEM VALPROIC ACID (VPA) REAGENT, a Calibrators, Drug Mixture (Class II — Special Controls, product code DKB), submitted by Beckman Instruments, Inc. (Brea, US). The FDA issued a Cleared decision on May 8, 1998, 21 days after receiving the submission on April 17, 1998. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3200.
Device Classification
| Product Code | DKB — Calibrators, Drug Mixture |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.3200 |
Manufacturer
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