THROMBO SCREEN QUANTITATIVE HEPARIN ASSA— 510(k) K770722

Name: FDA 510(k) clearance K770722
Creator: U.S. Food and Drug Administration
Published: 1977-07-11

Substantially Equivalent

Bay Area Hema. Onco. Clinic. & Res. L

FDA 510(k) clearance K770722 for THROMBO SCREEN QUANTITATIVE HEPARIN ASSA, Substantially Equivalent on 1977-07-11. Applicant: Bay Area Hema. Onco. Clinic. & Res. L. Device class: 2.

Clearance details

Applicant: Bay Area Hema. Onco. Clinic. & Res. L
Product code: Code JBR
Device class: Class 2
Regulation: 21 CFR 864.7525
Advisory panel: Hematology
Date received: 1977-04-19
Decision date: 1977-07-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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K925452 — DADE HEPZYME1993-01-11
K874373 — PT PRO-CLOT1988-01-05

More clearances from Bay Area Hema. Onco. Clinic. & Res. L

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K771678 — THROMBO-SCREEN PLATELET ADHESION1977-11-22
K770394 — THROMBO-SCREEN AT-111 KIT1977-03-30
K770395 — THROMBO-CETIN (RISTOCETIN)1977-03-21

Data sourced from openFDA. This site is unofficial and independent of the FDA.