SYNCHRON SYSTEMS ALCOHOL (ALC) REAGENT, SYNCHRON SYSTEMS ALCOHOL CALIBRATOR— 510(k) K971506
Substantially EquivalentBeckman Instruments, Inc.
FDA 510(k) clearance K971506 for SYNCHRON SYSTEMS ALCOHOL (ALC) REAGENT, SYNCHRON SYSTEMS ALCOHOL CALIBRATOR, Substantially Equivalent on 1997-06-03. Applicant: Beckman Instruments, Inc.. Device class: 2.
Clearance details
- Applicant
- Beckman Instruments, Inc.
- Product code
- Code DMT
- Device class
- Class 2
- Regulation
- 21 CFR 862.3040
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Brea, CA, US
Recent devices under product code DMT
view allMore clearances from Beckman Instruments, Inc.
view all- K973448 — ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 34460, 34465, 34469
- K982250 — ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
- 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.