Cleared Traditional

WASH SOLUTION KIT (K873130) - FDA 510(k) Clearance

Class I Chemistry device.

K873130 · A-Kem, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1987
Decision
74d
Days
Class 1
Risk

K873130 is an FDA 510(k) clearance for the WASH SOLUTION KIT. Classified as Analyzer, Chemistry (photometric, Discrete), For Clinical Use (product code JJE), Class I - General Controls.

Submitted by A-Kem, Inc. (Clifton, US). The FDA issued a Cleared decision on October 23, 1987 after a review of 74 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2160 - 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 A-Kem, Inc. devices

Submission Details

510(k) Number K873130 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1987
Decision Date October 23, 1987
Days to Decision 74 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 88d · This submission: 74d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJE Analyzer, Chemistry (photometric, Discrete), For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2160
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 - JJE Analyzer, Chemistry (photometric, Discrete), For Clinical Use

All 78
Devices cleared under the same product code (JJE) and FDA review panel - the closest regulatory comparables to K873130.
SYNCHRON CX(TM)5 CLINICAL ANALYZER
K881495 · Beckman Instruments, Inc. · Jun 1988
SYNCHRON CX(TM)4 CLINICAL ANALYZER
K881498 · Beckman Instruments, Inc. · Jun 1988
KODAK EKTACHEM 700 ANALYZER FAMILY, SOFTWARE V4.0
K874857 · Eastman Kodak Company · Feb 1988
EASY ST ANALYZER SYSTEM
K872813 · Em Diagnostic Systems, Inc. · Aug 1987
HITACHI 717 CHEMISTRY ANALYZER
K872494 · Boehringer Mannheim Corp. · Jul 1987
KODAK EKTACHEM 700XR ANALYZER
K872105 · Eastman Kodak Company · Jun 1987