Cleared Traditional

K981794 - HICHEM CALCIUM REAGENT KIT

K981794 is the FDA 510(k) clearance for HICHEM CALCIUM REAGENT KIT by Hichem Diagnostics. It is a Class 2 Chemistry device (product code CJY) cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K981794 · Hichem Diagnostics · Chemistry device

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Optimized for regulatory review, auditing and printing

Jul 1998

Decision

69d

Days

Class 2

Risk

K981794 is an FDA 510(k) clearance for the HICHEM CALCIUM REAGENT KIT. Classified as Azo Dye, Calcium (product code CJY), Class II - Special Controls.

Submitted by Hichem Diagnostics (Brea, US). The FDA issued a Cleared decision on July 29, 1998 after a review of 69 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1145 - 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 Hichem Diagnostics devices

Submission Details

510(k) Number	K981794 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 21, 1998
Decision Date	July 29, 1998
Days to Decision	69 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

19d faster than avg

Panel avg: 88d · This submission: 69d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code	CJY Azo Dye, Calcium
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 862.1145

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 - CJY Azo Dye, Calcium

All 33

Devices cleared under the same product code (CJY) and FDA review panel - the closest regulatory comparables to K981794.

OLYMPUS CALCIUM ARSENAZO REAGENT, OSR60117, OSR61117, OSR65117

K061575 · Olympus America, Inc. · Oct 2006

CALCIUM ADVANCE ASSAY, MODEL 145-20, 145-25, 145-20-91

K051757 · Diagnostic Chemicals , Ltd. · Nov 2005

MODIFICATION TO RAICHEM CALCIUM REAGENT

K022049 · Hemagen Diagnostics, Inc. · Jul 2002

K981578 · Abbott Laboratories · Jun 1998

RANDOX CALCIUM

K974607 · Randox Laboratories, Ltd. · Feb 1998

SIGMA DIAGNOSTICS CALICIUM REAGENT

K963536 · Sigma Diagnostics, Inc. · Oct 1996

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K981794

Hichem Diagnostics

Brea, CA · US

WYNN STOCKING

Regulatory profile

41 submissions 41 cleared

100% clearance rate · Active in Chemistry

Data Intelligence Layer

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