Cleared Traditional

K843758 - UROPAPER EIKEN GK

K843758 is the FDA 510(k) clearance for UROPAPER EIKEN GK by Syn-Kit, Inc.. It is a Class 2 Chemistry device (product code JIL) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K843758 · Syn-Kit, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1984
Decision
84d
Days
Class 2
Risk

K843758 is an FDA 510(k) clearance for the UROPAPER EIKEN GK. Classified as Method, Enzymatic, Glucose (urinary, Non-quantitative) (product code JIL), Class II - Special Controls.

Submitted by Syn-Kit, Inc. (Walker, US). The FDA issued a Cleared decision on December 18, 1984 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1340 - 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 Syn-Kit, Inc. devices

Submission Details

510(k) Number K843758 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1984
Decision Date December 18, 1984
Days to Decision 84 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
4d faster than avg
Panel avg: 88d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JIL Method, Enzymatic, Glucose (urinary, Non-quantitative)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1340
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 - JIL Method, Enzymatic, Glucose (urinary, Non-quantitative)

All 37
Devices cleared under the same product code (JIL) and FDA review panel - the closest regulatory comparables to K843758.
UROPAPER EIKEN 6B
K843755 · Syn-Kit, Inc. · Dec 1984
UROPAPER EIKEN 5
K843756 · Syn-Kit, Inc. · Dec 1984
UROPAPER EIKEN AG
K843757 · Syn-Kit, Inc. · Dec 1984
UROPAPER EIKEN HAG
K843759 · Syn-Kit, Inc. · Dec 1984
UROPAPER EIKEN G
K843760 · Syn-Kit, Inc. · Dec 1984
DIASTIX REAGENT STRIPS FOR URINALYSIS
K831600 · Miles Laboratories, Inc. · Sep 1983