IMMAGE IMMUNOCHEMISTRY SYSTEM MICROALBUMIN (MA) REAGENT— 510(k) K965035
Substantially EquivalentBeckman Instruments, Inc.
FDA 510(k) clearance K965035 for IMMAGE IMMUNOCHEMISTRY SYSTEM MICROALBUMIN (MA) REAGENT, Substantially Equivalent on 1997-04-17. Applicant: Beckman Instruments, Inc.. Device class: 1.
Clearance details
- Applicant
- Beckman Instruments, Inc.
- Product code
- Code JIQ
- Device class
- Class 1
- Regulation
- 21 CFR 862.1645
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Brea, CA, US
Recent devices under product code JIQ
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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
Data sourced from openFDA. This site is unofficial and independent of the FDA.