CX(TM) BARBITURATES(BARB) REAGENT FOR SYNCHRON CX SYST— 510(k) K944075
Substantially EquivalentBeckman Instruments, Inc.
FDA 510(k) clearance K944075 for CX(TM) BARBITURATES(BARB) REAGENT FOR SYNCHRON CX SYST, Substantially Equivalent on 1994-12-29. Applicant: Beckman Instruments, Inc.. Device class: 2.
Clearance details
- Applicant
- Beckman Instruments, Inc.
- Product code
- Code DIS
- Device class
- Class 2
- Regulation
- 21 CFR 862.3150
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Brea, CA, US
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Recalls naming K944075
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K944075.
Data sourced from openFDA. This site is unofficial and independent of the FDA.