GENERAL DIAG. CHROMOSTRATE HEPARIN ASSAY— 510(k) K850486
Substantially EquivalentWarner-Lambert Co.
FDA 510(k) clearance K850486 for GENERAL DIAG. CHROMOSTRATE HEPARIN ASSAY, Substantially Equivalent on 1985-05-08. Applicant: Warner-Lambert Co.. Device class: 2.
Clearance details
- Applicant
- Warner-Lambert Co.
- Product code
- Code KFF
- Device class
- Class 2
- Regulation
- 21 CFR 864.7525
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Morris Plains, NJ, US
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