COAGULATION EXTRINSIC DEFICIENT PLASMAS— 510(k) K864497
Substantially EquivalentInstrumentation Laboratory CO
FDA 510(k) clearance K864497 for COAGULATION EXTRINSIC DEFICIENT PLASMAS, Substantially Equivalent on 1987-01-05. Applicant: Instrumentation Laboratory CO. Device class: 2.
Clearance details
- Applicant
- Instrumentation Laboratory CO
- Product code
- Code GGP
- Device class
- Class 2
- Regulation
- 21 CFR 864.7290
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lexington, MA, US
Recent devices under product code GGP
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