Cleared Traditional

K800780 - SANDARE LYOPHILIZED HEMOGLOBIN CONTROLS

K800780 is the FDA 510(k) clearance for SANDARE LYOPHILIZED HEMOGLOBIN CONTROLS by Sandare Chemical Co., Inc.. It is a Class 2 Hematology device (product code JPK) cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K800780 · Sandare Chemical Co., Inc. · Hematology device
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Apr 1980
Decision
16d
Days
Class 2
Risk

K800780 is an FDA 510(k) clearance for the SANDARE LYOPHILIZED HEMOGLOBIN CONTROLS. Classified as Mixture, Hematology Quality Control (product code JPK), Class II - Special Controls.

Submitted by Sandare Chemical Co., Inc. (Walker, US). The FDA issued a Cleared decision on April 24, 1980 after a review of 16 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 Sandare Chemical Co., Inc. devices

Submission Details

510(k) Number K800780 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1980
Decision Date April 24, 1980
Days to Decision 16 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 113d · This submission: 16d
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 144
Devices cleared under the same product code (JPK) and FDA review panel - the closest regulatory comparables to K800780.
CH-60 PLUS WHOLE BLOOD PLATELET CONTROL
K802141 · American Dade · Oct 1980
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
WHOLE BLOOD PLATELET CONTROL NORMAL,
K792606 · Dade, Baxter Travenol Diagnostics, Inc. · Feb 1980
PLATELET-CHEX FOR BLOOD CENTERS
K792467 · Streck Laboratories, Inc. · Dec 1979