SYNCHRON SYSTEMS RHEUMATOID FACTOR (RF) REAGENT, SYNCHRON CX SYSTEMS RF CALIBRATOR— 510(k) K971788
Substantially EquivalentBeckman Instruments, Inc.
FDA 510(k) clearance K971788 for SYNCHRON SYSTEMS RHEUMATOID FACTOR (RF) REAGENT, SYNCHRON CX SYSTEMS RF CALIBRATOR, Substantially Equivalent on 1997-06-03. Applicant: Beckman Instruments, Inc.. Device class: 2.
Clearance details
- Applicant
- Beckman Instruments, Inc.
- Product code
- Code DHR
- Device class
- Class 2
- Regulation
- 21 CFR 866.5775
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Brea, CA, US
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