Cleared Traditional

K781562 - HEMACHECK

K781562 is an FDA 510(k) clearance for HEMACHECK, manufactured by Vickers America Medical Corp.. The device is a Class 2 Chemistry device with product code GKL cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K781562 · Vickers America Medical Corp. · Chemistry device
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Nov 1978
Decision
65d
Days
Class 2
Risk

K781562 is an FDA 510(k) clearance for the HEMACHECK. Classified as Counter, Cell, Automated (particle Counter) (product code GKL), Class II - Special Controls.

Submitted by Vickers America Medical Corp. (Mchenry, US). The FDA issued a Cleared decision on November 15, 1978 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 864.5200 - the FDA in vitro diagnostics and chemistry 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 Vickers America Medical Corp. devices

FDA 510(k) Submission Details - K781562

510(k) Number K781562 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1978
Decision Date November 15, 1978
Days to Decision 65 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 88d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GKL Device Classification - Class 2, Special Controls

Product Code GKL Counter, Cell, Automated (particle Counter)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5200
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 Chemistry devices follow this clearance model.

Regulatory Peers - GKL Counter, Cell, Automated (particle Counter)

All 95
Devices cleared under the same product code (GKL) and FDA review panel - the closest regulatory comparables to K781562.
HYCEL COUNTER 333
K782100 · Hycel, Inc. · Jan 1979
HYCEL COUNTER 222
K782101 · Hycel, Inc. · Jan 1979
HYCEL COUNTER 211
K782102 · Hycel, Inc. · Jan 1979
HEMO-W SYSTEM
K781628 · Coulter Electronics, Inc. · Oct 1978
SYSMEX AUTO. BLOOD CELL COUNTER, CC-120
K780909 · Toa Medical Electronics USA, Inc. · Jun 1978
SYSTEM AUTO. BLOOD CELL COUNTER CC-110
K780910 · Toa Medical Electronics USA, Inc. · Jun 1978