HEMOCUE HEMOLIN— 510(k) K963908

Substantially Equivalent

Direct Solutions

FDA 510(k) clearance K963908 for HEMOCUE HEMOLIN, Substantially Equivalent on 1996-10-16. Applicant: Direct Solutions. Device class: 2.

Clearance details

Applicant: Direct Solutions
Product code: Code GGM
Device class: Class 2
Regulation: 21 CFR 864.8625
Advisory panel: Hematology
Date received: 1996-09-30
Decision date: 1996-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westford, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GGM

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K070546 — LYPHOCHEK DIABETES CONTROL2007-04-02
K070334 — R&D SICKLE QC CONTROL2007-03-29
K052838 — LIQUICHEK DIABETES CONTROL, LEVEL 1,2,3,42005-11-09

More clearances from Direct Solutions

K963909 — HEMOCUE GLUCOLIN1996-11-08
K964052 — HEMOCUE HEMOTROL1996-11-06
K964053 — HEMOCUE GLUCOTROL1996-11-01
K955340 — EUROTROL GAS - ISE CONTROL1995-12-26

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