Cleared Traditional

K841664 - ENZYMATIC CO2 DIAGNOSTIC CHEMICAL

K841664 is the FDA 510(k) clearance for ENZYMATIC CO2 DIAGNOSTIC CHEMICAL by Diagnostic Chemicals, Ltd. (Usa). It is a Class 2 Chemistry device (product code KHS) cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K841664 · Diagnostic Chemicals, Ltd. (Usa) · Chemistry device
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Jun 1984
Decision
46d
Days
Class 2
Risk

K841664 is an FDA 510(k) clearance for the ENZYMATIC CO2 DIAGNOSTIC CHEMICAL. Classified as Enzymatic, Carbon-dioxide (product code KHS), Class II - Special Controls.

Submitted by Diagnostic Chemicals, Ltd. (Usa) (Walker, US). The FDA issued a Cleared decision on June 8, 1984 after a review of 46 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1160 - 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 Diagnostic Chemicals, Ltd. (Usa) devices

Submission Details

510(k) Number K841664 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1984
Decision Date June 08, 1984
Days to Decision 46 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
42d faster than avg
Panel avg: 88d · This submission: 46d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KHS Enzymatic, Carbon-dioxide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1160
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 - KHS Enzymatic, Carbon-dioxide

All 65
Devices cleared under the same product code (KHS) and FDA review panel - the closest regulatory comparables to K841664.
RAICHEM CO2 REAGENT
K854544 · Reagents Applications, Inc. · Dec 1985
DATA ZYME CO2 PROCEDURE
K850903 · Data Medical Associates, Inc. · Apr 1985
ROCHE REAGENTS REAGENT FOR CO2
K844987 · Roche Diagnostic Systems, Inc. · Jan 1985
CARBON DIOXIDE REAGENT
K840773 · American Dade · Apr 1984
ENZYMATIC CO2
K822079 · American Monitor Corp. · Jul 1982
BICARBONATE TEST
K810356 · Boehringer Mannheim Corp. · Feb 1981