MICROHEMATOCRIT TUBES, HEPARIN & MICROHEMA TUBE,PL— 510(k) K881186

Name: FDA 510(k) clearance K881186
Creator: U.S. Food and Drug Administration
Published: 1988-05-13

Substantially Equivalent

Helps Products, Inc.

FDA 510(k) clearance K881186 for MICROHEMATOCRIT TUBES, HEPARIN & MICROHEMA TUBE,PL, Substantially Equivalent on 1988-05-13. Applicant: Helps Products, Inc.. Device class: 2.

Clearance details

Applicant: Helps Products, Inc.
Product code: Code GHY
Device class: Class 2
Regulation: 21 CFR 864.6400
Advisory panel: Hematology
Date received: 1988-03-21
Decision date: 1988-05-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orlando, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GHY

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K883185 — SAFECRIT PLASTIC MICROHEMATOCRIT TUBES1988-08-18

More clearances from Helps Products, Inc.

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K881188 — BLOOD PH CAPILLARY TUBES, HEPARIN1988-07-08
K881187 — NATELSON TUBES, HEPARIN AND PLAIN1988-05-06
K881262 — CARAWAY TUBES, HEPARIN AND PLAIN1988-05-06

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