Cleared Traditional

K943684 - HICHEM ENZYME VERIFIER KIT

K943684 is an FDA 510(k) clearance for HICHEM ENZYME VERIFIER KIT, manufactured by Hi Chem, Inc.. The device is a Class 1 Chemistry device with product code JJT cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K943684 · Hi Chem, Inc. · Chemistry device
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Oct 1994
Decision
67d
Days
Class 1
Risk

K943684 is an FDA 510(k) clearance for the HICHEM ENZYME VERIFIER KIT. Classified as Enzyme Controls (assayed And Unassayed) (product code JJT), Class I - General Controls.

Submitted by Hi Chem, Inc. (Brea, US). The FDA issued a Cleared decision on October 4, 1994 after a review of 67 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - 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.

FDA 510(k) Submission Details - K943684

510(k) Number K943684 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1994
Decision Date October 04, 1994
Days to Decision 67 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 89d · This submission: 67d
Pathway characteristics
Predicate-based equivalence.

JJT Device Classification - Class 1, General Controls

Product Code JJT Enzyme Controls (assayed And Unassayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
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 - JJT Enzyme Controls (assayed And Unassayed)

All 96
Devices cleared under the same product code (JJT) and FDA review panel - the closest regulatory comparables to K943684.
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K930889 · Roche Diagnostic Systems, Inc. · Jul 1993
CKMB ISOENZYME CONTROL-LEVEL 1,2.3
K930873 · Cala Diagnostics · Apr 1993
K943684 · HICHEM ENZYME VERIFIER KIT
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