CARBAMEZEPINE REAGENT TEST KIT— 510(k) K831222
Substantially EquivalentBeckman Instruments, Inc.
FDA 510(k) clearance K831222 for CARBAMEZEPINE REAGENT TEST KIT, Substantially Equivalent on 1983-05-09. Applicant: Beckman Instruments, Inc.. Device class: 2.
Clearance details
- Applicant
- Beckman Instruments, Inc.
- Product code
- Code KLT
- Device class
- Class 2
- Regulation
- 21 CFR 862.3645
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code KLT
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- K981403 — IMMAGE IMMUNOCHEMISTRY SYSTEM VALPROIC ACID (VPA) REAGENT
- K981354 — ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211
- K980173 — ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER; 33500, 33505
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