Cleared Traditional

K800361 - HEMATO-CHEX

K800361 is an FDA 510(k) clearance for HEMATO-CHEX, manufactured by Streck Laboratories, Inc.. The device is a Class 2 Hematology device with product code JPK cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K800361 · Streck Laboratories, Inc. · Hematology device
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Apr 1980
Decision
44d
Days
Class 2
Risk

K800361 is an FDA 510(k) clearance for the HEMATO-CHEX. Classified as Mixture, Hematology Quality Control (product code JPK), Class II - Special Controls.

Submitted by Streck Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 4, 1980 after a review of 44 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 Streck Laboratories, Inc. devices

FDA 510(k) Submission Details - K800361

510(k) Number K800361 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 1980
Decision Date April 04, 1980
Days to Decision 44 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
69d faster than avg
Panel avg: 113d · This submission: 44d
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 K800361.
CH-60 PLUS WHOLE BLOOD PLATELET/ABNORNAL
K802142 · American Dade · Oct 1980
CH-60 PLUS /ABNORMAL LOW/BLOOD PLATELET
K802143 · American Dade · Oct 1980
SANDARE LYOPHILIZED HEMOGLOBIN CONTROLS
K800780 · Sandare Chemical Co., Inc. · Apr 1980
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