Cleared Traditional

K780635 - REAGENT SET HDL CHOLESTEROL

K780635 is an FDA 510(k) clearance for REAGENT SET HDL CHOLESTEROL, manufactured by Boehringer Mannheim Corp.. The device is a Class 1 Chemistry device with product code CHH cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K780635 · Boehringer Mannheim Corp. · Chemistry device
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May 1978
Decision
32d
Days
Class 1
Risk

K780635 is an FDA 510(k) clearance for the REAGENT SET HDL CHOLESTEROL. Classified as Enzymatic Esterase--oxidase, Cholesterol (product code CHH), Class I - General Controls.

Submitted by Boehringer Mannheim Corp. (Mchenry, US). The FDA issued a Cleared decision on May 19, 1978 after a review of 32 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 Boehringer Mannheim Corp. devices

FDA 510(k) Submission Details - K780635

510(k) Number K780635 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1978
Decision Date May 19, 1978
Days to Decision 32 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
56d faster than avg
Panel avg: 88d · This submission: 32d
Pathway characteristics
Predicate-based equivalence.

CHH Device Classification - Class 1, General Controls

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 137
Devices cleared under the same product code (CHH) and FDA review panel - the closest regulatory comparables to K780635.
ENZYMATIC REAGENT FOR CHOLESTEROL MEAS
K781013 · Coulter Electronics, Inc. · Jul 1978
AUTOZYME CHOLESTEROL-OXIDASE REAGENT KIT
K780783 · J.T. Baker Chemical Co. · Jun 1978
ULTRACHEM ENZYMATIC CHOLESTEROL 65025
K780523 · Harleco · May 1978
CHOLAR PRODU&T #17010
K771731 · Hi Chem, Inc. · Oct 1977
MULTISTAT III CHOLESTEROL TEST
K771508 · Instrumentation Laboratory CO · Sep 1977
HOLESTEROL DELTA TEST ASSAY
K771582 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1977