IMMAGE IMMUNOCHEMISTRY SYSTEM ALBUMIN (ALB) REAGENT— 510(k) K964695
Substantially EquivalentBeckman Instruments, Inc.
FDA 510(k) clearance K964695 for IMMAGE IMMUNOCHEMISTRY SYSTEM ALBUMIN (ALB) REAGENT, Substantially Equivalent on 1997-04-29. Applicant: Beckman Instruments, Inc.. Device class: 2.
Clearance details
- Applicant
- Beckman Instruments, Inc.
- Product code
- Code DCF
- Device class
- Class 2
- Regulation
- 21 CFR 866.5040
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Brea, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.