Cleared Traditional

K791772 - COUNTER-CHECK PLUS NORMAL

K791772 is an FDA 510(k) clearance for COUNTER-CHECK PLUS NORMAL, manufactured by Diagnostic Technology, Inc.. The device is a Class 2 Hematology device with product code JPK cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K791772 · Diagnostic Technology, Inc. · Hematology device
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Oct 1979
Decision
34d
Days
Class 2
Risk

K791772 is an FDA 510(k) clearance for the COUNTER-CHECK PLUS NORMAL, HIGH ABN.. Classified as Mixture, Hematology Quality Control (product code JPK), Class II - Special Controls.

Submitted by Diagnostic Technology, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 11, 1979 after a review of 34 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 Diagnostic Technology, Inc. devices

FDA 510(k) Submission Details - K791772

510(k) Number K791772 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 1979
Decision Date October 11, 1979
Days to Decision 34 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 113d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JPK Device Classification - Class 2, Special Controls

Product Code JPK Mixture, Hematology Quality Control
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 - JPK Mixture, Hematology Quality Control

All 160
Devices cleared under the same product code (JPK) and FDA review panel - the closest regulatory comparables to K791772.
SANDARE HEMOGLOBIN CONTROLS
K792209 · Sandare Chemical Co., Inc. · Dec 1979
FISHER DIAGNOSTICS HEMATOLOGY CONTROLS
K792055 · Fisher Scientific Co., LLC · Nov 1979
COUNTER-CHECK PLUS
K791750 · Diagnostic Technology, Inc. · Oct 1979
PLATELET-CHEX PLUS
K791226 · Streck Laboratories, Inc. · Aug 1979
PARA-7
K791227 · Streck Laboratories, Inc. · Aug 1979
PARA-8
K791228 · Streck Laboratories, Inc. · Aug 1979