Cleared Traditional

K903365 - KETOREX SANWA STANDARDS

K903365 is an FDA 510(k) clearance for KETOREX SANWA STANDARDS, manufactured by Ihara Medics U.S., Inc.. The device is a Class 1 Chemistry device with product code JIN cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K903365 · Ihara Medics U.S., Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1990
Decision
147d
Days
Class 1
Risk

K903365 is an FDA 510(k) clearance for the KETOREX SANWA STANDARDS. Classified as Nitroprusside, Ketones (urinary, Non-quant.) (product code JIN), Class I - General Controls.

Submitted by Ihara Medics U.S., Inc. (Valencia, US). The FDA issued a Cleared decision on December 20, 1990 after a review of 147 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1435 - 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 Ihara Medics U.S., Inc. devices

FDA 510(k) Submission Details - K903365

510(k) Number K903365 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1990
Decision Date December 20, 1990
Days to Decision 147 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d slower than avg
Panel avg: 88d · This submission: 147d
Pathway characteristics
Predicate-based equivalence.

JIN Device Classification - Class 1, General Controls

Product Code JIN Nitroprusside, Ketones (urinary, Non-quant.)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1435
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JIN Nitroprusside, Ketones (urinary, Non-quant.)

All 14
Devices cleared under the same product code (JIN) and FDA review panel - the closest regulatory comparables to K903365.
URS-1K (KETONE TESST)
K003987 · Teco Diagnostics · Apr 2001
FIRST CHOICE KETONES URINE TEST STRIPS
K953662 · Polymer Technology Intl. · Jun 1996
FIRST CHOICE GLUCOSE & KETONES URINE TEST STRIPS
K953680 · Polymer Technology Intl. · Jun 1996
ABBOTT BREATH ACETONE ANALYZER
K875029 · Abbott Laboratories · May 1988
SIGMS B-HYDROXYBUTARATE PROCEDURE NO. 310-UV
K850368 · Sigma Chemical Co. · Aug 1985
HELENA BIOSTRIP K
K830976 · Helena Laboratories · May 1983