PLATELET RETENTION (ADHESION) COLUMNS— 510(k) K800037

Name: FDA 510(k) clearance K800037
Creator: U.S. Food and Drug Administration
Published: 1980-02-05

Substantially Equivalent

Hemometrix

FDA 510(k) clearance K800037 for PLATELET RETENTION (ADHESION) COLUMNS, Substantially Equivalent on 1980-02-05. Applicant: Hemometrix. Device class: 2.

Clearance details

Applicant: Hemometrix
Product code: Code JBZ
Device class: Class 2
Regulation: 21 CFR 864.6650
Advisory panel: Hematology
Date received: 1980-01-07
Decision date: 1980-02-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K771523 — LATELET RETENTION COLUMN1977-11-22
K771678 — THROMBO-SCREEN PLATELET ADHESION1977-11-22

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K792261 — GENTAMICIN CONTROL SERUM1979-12-18
K792262 — GENTAMICIN LIQUID CONTROL SERUM1979-12-18
K792263 — TOBRAMYCIN CONTROL SERUM1979-12-18

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