Cleared Traditional

K792606 - WHOLE BLOOD PLATELET CONTROL NORMAL

K792606 is the FDA 510(k) clearance for WHOLE BLOOD PLATELET CONTROL NORMAL by Dade, Baxter Travenol Diagnostics, Inc.. It is a Class 2 Hematology device (product code JPK) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K792606 · Dade, Baxter Travenol Diagnostics, Inc. · Hematology device
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Feb 1980
Decision
57d
Days
Class 2
Risk

K792606 is an FDA 510(k) clearance for the WHOLE BLOOD PLATELET CONTROL NORMAL,. Classified as Mixture, Hematology Quality Control (product code JPK), Class II - Special Controls.

Submitted by Dade, Baxter Travenol Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 13, 1980 after a review of 57 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 Dade, Baxter Travenol Diagnostics, Inc. devices

Submission Details

510(k) Number K792606 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1979
Decision Date February 13, 1980
Days to Decision 57 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
56d faster than avg
Panel avg: 113d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 141
Devices cleared under the same product code (JPK) and FDA review panel - the closest regulatory comparables to K792606.
CH-60 PLUS WHOLE BLOOD PLATELET/ABNORNAL
K802142 · American Dade · Oct 1980
CH-60 PLUS /ABNORMAL LOW/BLOOD PLATELET
K802143 · American Dade · Oct 1980
HEMATO-CHEX
K800361 · Streck Laboratories, Inc. · Apr 1980
PLATELET-CHEX FOR BLOOD CENTERS
K792467 · Streck Laboratories, Inc. · Dec 1979
FISHER DIAGNOSTICS HEMATOLOGY CONTROLS
K792055 · Fisher Scientific Co., LLC · Nov 1979
PLATELET-CHEX PLUS
K791226 · Streck Laboratories, Inc. · Aug 1979