FIBRINOGEN HIGH ABNORMAL CONTROL - LEVEL 3— 510(k) K946265
Substantially EquivalentClinical Controls, Inc.
FDA 510(k) clearance K946265 for FIBRINOGEN HIGH ABNORMAL CONTROL - LEVEL 3, Substantially Equivalent on 1995-08-24. Applicant: Clinical Controls, Inc.. Device class: 2.
Clearance details
- Applicant
- Clinical Controls, Inc.
- Product code
- Code GIL
- Device class
- Class 2
- Regulation
- 21 CFR 864.7340
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Grover Beach, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.