Cleared Traditional

K861508 - WAKO MICRO TP

K861508 is the FDA 510(k) clearance for WAKO MICRO TP by Wako Chemicals USA, Inc.. It is a Class 2 Chemistry device (product code CEK) cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K861508 · Wako Chemicals USA, Inc. · Chemistry device
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Aug 1986
Decision
118d
Days
Class 2
Risk

K861508 is an FDA 510(k) clearance for the WAKO MICRO TP. Classified as Biuret (colorimetric), Total Protein (product code CEK), Class II - Special Controls.

Submitted by Wako Chemicals USA, Inc. (Dallas, US). The FDA issued a Cleared decision on August 19, 1986 after a review of 118 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Wako Chemicals USA, Inc. devices

Submission Details

510(k) Number K861508 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1986
Decision Date August 19, 1986
Days to Decision 118 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
30d slower than avg
Panel avg: 88d · This submission: 118d
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 76
Devices cleared under the same product code (CEK) and FDA review panel - the closest regulatory comparables to K861508.
BIURET (COLORIMETRIC), TOTAL PROTEIN
K864743 · Tech-Co, Inc. · Jan 1987
TOTAL PROTEIN PROCEDURE
K863258 · Data Medical Associates, Inc. · Sep 1986
EMDS(TM) TOTAL PROTEIN TESTPACKS, #67663/95
K863005 · Em Diagnostic Systems, Inc. · Aug 1986
VISION TOTAL PROTEIN
K861798 · Abbott Laboratories · Jun 1986
TOTAL PROTEIN PROCEDURE
K861663 · Data Medical Associates, Inc. · Jun 1986
EASY-TEST TOTAL PROTEIN (TP), #67513/93
K860917 · Em Diagnostic Systems, Inc. · Apr 1986