Cleared Traditional

K781013 - ENZYMATIC REAGENT FOR CHOLESTEROL MEAS

K781013 is the FDA 510(k) clearance for ENZYMATIC REAGENT FOR CHOLESTEROL MEAS by Coulter Electronics, Inc.. It is a Class 1 Chemistry device (product code CHH) cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K781013 · Coulter Electronics, Inc. · Chemistry device
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Jul 1978
Decision
42d
Days
Class 1
Risk

K781013 is an FDA 510(k) clearance for the ENZYMATIC REAGENT FOR CHOLESTEROL MEAS. Classified as Enzymatic Esterase--oxidase, Cholesterol (product code CHH), Class I - General Controls.

Submitted by Coulter Electronics, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 28, 1978 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1175 - 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 Coulter Electronics, Inc. devices

Submission Details

510(k) Number K781013 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 1978
Decision Date July 28, 1978
Days to Decision 42 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
46d faster than avg
Panel avg: 88d · This submission: 42d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CHH Enzymatic Esterase--oxidase, Cholesterol
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1175
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 - CHH Enzymatic Esterase--oxidase, Cholesterol

All 121
Devices cleared under the same product code (CHH) and FDA review panel - the closest regulatory comparables to K781013.
CHOLESTEROL REAGENT, AUTOMATED ENZYMATIC
K790556 · Calbiochem-Behring Corp. · May 1979
REAGENT, HDL
K781740 · Fisher Scientific Co., LLC · Nov 1978
REAGENT SET, CHOLESTEROL
K781721 · Medical Analysis Systems, Inc. · Nov 1978
AUTOZYME CHOLESTEROL-OXIDASE REAGENT KIT
K780783 · J.T. Baker Chemical Co. · Jun 1978
ULTRACHEM ENZYMATIC CHOLESTEROL 65025
K780523 · Harleco · May 1978
REAGENT SET HDL CHOLESTEROL
K780635 · Boehringer Mannheim Corp. · May 1978