Cleared Traditional

K843532 - UROPAPER EIKEN 8

K843532 is an FDA 510(k) clearance for UROPAPER EIKEN 8, manufactured by Syn-Kit, Inc.. The device is a Class 2 Chemistry device with product code KHE cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K843532 · Syn-Kit, Inc. · Chemistry device
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Dec 1984
Decision
96d
Days
Class 2
Risk

K843532 is an FDA 510(k) clearance for the UROPAPER EIKEN 8. Classified as Reagent, Occult Blood (product code KHE), Class II - Special Controls.

Submitted by Syn-Kit, Inc. (Chatsworth, US). The FDA issued a Cleared decision on December 12, 1984 after a review of 96 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 864.6550 - 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.

FDA 510(k) Submission Details - K843532

510(k) Number K843532 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 1984
Decision Date December 12, 1984
Days to Decision 96 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
7d slower than avg
Panel avg: 89d · This submission: 96d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KHE Device Classification - Class 2, Special Controls

Product Code KHE Reagent, Occult Blood
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.6550
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 - KHE Reagent, Occult Blood

All 96
Devices cleared under the same product code (KHE) and FDA review panel - the closest regulatory comparables to K843532.
ACCESS DIGIWIPE SYSTEM
K853141 · Medtech Products, Inc. · Nov 1985
EZ-DETECT VISUAL COLOR TEST FOR BLOOD IN STOOL
K850431 · Nms Pharmaceuticals, Inc. · Jun 1985
ACCESS HEMAWIPE
K843601 · Medtech Products, Inc. · Jan 1985
COLOSCREEN SELF-TEST
K843352 · Helena Laboratories · Dec 1984
COLOTRAK OCCULT BLOOD TEST
K840527 · Breit Laboratories, Inc. · Sep 1984
OCCULT BLOOD TEST
K842137 · Breit Laboratories, Inc. · Sep 1984
K843532 · UROPAPER EIKEN 8
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