Cleared Traditional

K802156 - REAGENTS SERUM CREATINE USING TECHICON

K802156 is the FDA 510(k) clearance for REAGENTS SERUM CREATINE USING TECHICON by Panmed, Inc.. It is a Class 2 Chemistry device (product code CGX) cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K802156 · Panmed, Inc. · Chemistry device
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Oct 1980
Decision
32d
Days
Class 2
Risk

K802156 is an FDA 510(k) clearance for the REAGENTS SERUM CREATINE USING TECHICON. Classified as Alkaline Picrate, Colorimetry, Creatinine (product code CGX), Class II - Special Controls.

Submitted by Panmed, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 10, 1980 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1225 - the FDA in vitro diagnostics and chemistry 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 Panmed, Inc. devices

Submission Details

510(k) Number K802156 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 1980
Decision Date October 10, 1980
Days to Decision 32 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 88d · This submission: 32d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CGX Alkaline Picrate, Colorimetry, Creatinine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1225
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 Chemistry devices follow this clearance model.

Regulatory Peers - CGX Alkaline Picrate, Colorimetry, Creatinine

All 113
Devices cleared under the same product code (CGX) and FDA review panel - the closest regulatory comparables to K802156.
CREATININE REAGENT
K811659 · Gilford Diagnostics · Jun 1981
CREATININE TEST
K811664 · King Diagnostics, Inc. · Jun 1981
LANCER CREATININE MICROSAMPLE STAT ANA
K803087 · Sherwood Medical Co. · Jan 1981
SERUM CREATININE
K800219 · Fisher Scientific Co., LLC · Feb 1980
ELVI CREATININE
K792397 · Volu Sol Medical Industries · Dec 1979
ELVI CREATININ
K792402 · Volu Sol Medical Industries · Dec 1979