FIBRINOGEN FDP CONTROL— 510(k) K915503

Substantially Equivalent

Cala Diagnostics

FDA 510(k) clearance K915503 for FIBRINOGEN FDP CONTROL, Substantially Equivalent on 1992-01-30. Applicant: Cala Diagnostics. Device class: 2.

Clearance details

Applicant: Cala Diagnostics
Product code: Code DAP
Device class: Class 2
Regulation: 21 CFR 864.7320
Advisory panel: Hematology
Date received: 1991-12-09
Decision date: 1992-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Osos, CA, US

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More clearances from Cala Diagnostics

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K930874 — LD-1 CONTROL-LEVEL 1 & 21993-04-22
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Data sourced from openFDA. This site is unofficial and independent of the FDA.