Cleared Traditional

K864743 - BIURET (COLORIMETRIC)

K864743 is the FDA 510(k) clearance for BIURET (COLORIMETRIC) by Tech-Co, Inc.. It is a Class 2 Chemistry device (product code CEK) cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K864743 · Tech-Co, Inc. · Chemistry device
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Jan 1987
Decision
40d
Days
Class 2
Risk

K864743 is an FDA 510(k) clearance for the BIURET (COLORIMETRIC), TOTAL PROTEIN. Classified as Biuret (colorimetric), Total Protein (product code CEK), Class II - Special Controls.

Submitted by Tech-Co, Inc. (Troy, US). The FDA issued a Cleared decision on January 13, 1987 after a review of 40 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1635 - 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 Tech-Co, Inc. devices

Submission Details

510(k) Number K864743 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1986
Decision Date January 13, 1987
Days to Decision 40 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 88d · This submission: 40d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CEK Biuret (colorimetric), Total Protein
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1635
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 - CEK Biuret (colorimetric), Total Protein

All 77
Devices cleared under the same product code (CEK) and FDA review panel - the closest regulatory comparables to K864743.
TOTAL PROTEIN
K875222 · Catachem, Inc. · Jan 1988
EASY-TEST TOTAL PROTEIN (TP) ITEM NUMBER: 19011
K874476 · Em Diagnostic Systems, Inc. · Nov 1987
TOTAL PROTEIN REAGENT - BIURET METHOD
K870371 · Trace Scientific , Ltd. · Aug 1987
TOTAL PROTEIN PROCEDURE
K863258 · Data Medical Associates, Inc. · Sep 1986
TOTAL PROTEINS
K863074 · J. D. Assoc. · Sep 1986
EMDS(TM) TOTAL PROTEIN TESTPACKS, #67663/95
K863005 · Em Diagnostic Systems, Inc. · Aug 1986