Cleared Traditional

K963908 - HEMOCUE HEMOLIN

K963908 is an FDA 510(k) clearance for HEMOCUE HEMOLIN, manufactured by Direct Solutions. The device is a Class 2 Hematology device with product code GGM cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K963908 · Direct Solutions · Hematology device
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Oct 1996
Decision
16d
Days
Class 2
Risk

K963908 is an FDA 510(k) clearance for the HEMOCUE HEMOLIN. Classified as Control, Hemoglobin (product code GGM), Class II - Special Controls.

Submitted by Direct Solutions (Westford, US). The FDA issued a Cleared decision on October 16, 1996 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.8625 - the FDA hematology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Direct Solutions devices

FDA 510(k) Submission Details - K963908

510(k) Number K963908 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1996
Decision Date October 16, 1996
Days to Decision 16 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 113d · This submission: 16d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GGM Device Classification - Class 2, Special Controls

Product Code GGM Control, Hemoglobin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.8625
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.

Regulatory Peers - GGM Control, Hemoglobin

All 13
Devices cleared under the same product code (GGM) and FDA review panel - the closest regulatory comparables to K963908.
LYPHOCHEK HEMOGLOBIN ALC LINEARITY SET
K003030 · Bio-Rad · Nov 2000
R&D HGB/GLC WHOLE BLOOD CONTROL
K993321 · R&D Systems, Inc. · Nov 1999
HEMOCUE HEMOTROL
K964052 · Direct Solutions · Nov 1996
CRITERION, HEMOCUE B-HEMOGLOBIN CONTROL
K921681 · Isolab, Inc. · Nov 1992
HGB-CONTROL SET/MULTIPLE
K893985 · R&D Systems, Inc. · Aug 1989
PRECINORM HB
K852136 · Boehringer Mannheim Corp. · Jul 1985