Cleared Traditional

K792055 - FISHER DIAGNOSTICS HEMATOLOGY CONTROLS

K792055 is an FDA 510(k) clearance for FISHER DIAGNOSTICS HEMATOLOGY CONTROLS, manufactured by Fisher Scientific Co., LLC. The device is a Class 2 Hematology device with product code JPK cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K792055 · Fisher Scientific Co., LLC · Hematology device
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Nov 1979
Decision
21d
Days
Class 2
Risk

K792055 is an FDA 510(k) clearance for the FISHER DIAGNOSTICS HEMATOLOGY CONTROLS. Classified as Mixture, Hematology Quality Control (product code JPK), Class II - Special Controls.

Submitted by Fisher Scientific Co., LLC (Mchenry, US). The FDA issued a Cleared decision on November 5, 1979 after a review of 21 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 Fisher Scientific Co., LLC devices

FDA 510(k) Submission Details - K792055

510(k) Number K792055 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1979
Decision Date November 05, 1979
Days to Decision 21 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
92d faster than avg
Panel avg: 113d · This submission: 21d
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 166
Devices cleared under the same product code (JPK) and FDA review panel - the closest regulatory comparables to K792055.
WHOLE BLOOD PLATELET CONTROL NORMAL,
K792606 · Dade, Baxter Travenol Diagnostics, Inc. · Feb 1980
PLATELET-CHEX FOR BLOOD CENTERS
K792467 · Streck Laboratories, Inc. · Dec 1979
SANDARE HEMOGLOBIN CONTROLS
K792209 · Sandare Chemical Co., Inc. · Dec 1979
COUNTER-CHECK PLUS
K791750 · Diagnostic Technology, Inc. · Oct 1979
COUNTER-CHECK PLUS NORMAL, HIGH ABN.
K791772 · Diagnostic Technology, Inc. · Oct 1979
PLATELET-CHEX PLUS
K791226 · Streck Laboratories, Inc. · Aug 1979