Cleared Traditional

K772043 - ALPHA/CHOL

K772043 is the FDA 510(k) clearance for ALPHA/CHOL by Standard Scientific, Inc.. It is a Class 1 Hematology device (product code CGO) cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K772043 · Standard Scientific, Inc. · Hematology device
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Nov 1977
Decision
31d
Days
Class 1
Risk

K772043 is an FDA 510(k) clearance for the ALPHA/CHOL. Classified as Lieberman-burchard/abell-kendall, Colorimetric, Cholesterol (product code CGO), Class I - General Controls.

Submitted by Standard Scientific, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 28, 1977 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 862.1175 - the FDA hematology device 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 Standard Scientific, Inc. devices

Submission Details

510(k) Number K772043 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1977
Decision Date November 28, 1977
Days to Decision 31 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 113d · This submission: 31d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CGO Lieberman-burchard/abell-kendall, Colorimetric, 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 - CGO Lieberman-burchard/abell-kendall, Colorimetric, Cholesterol

Devices cleared under the same product code (CGO) and FDA review panel - the closest regulatory comparables to K772043.
KING DIAGNOSTICS CHOLESTEROL TEST
K811747 · King Diagnostics, Inc. · Jul 1981
CHOLESTEROL DET. IN SERUM
K781611 · Fisher Scientific Co., LLC · Oct 1978
SR-PLUS DIRECT CHOLESTEROL TEST
K780545 · Stanbio Laboratory · May 1978
CHOLESTEROL REAGENT
K771313 · Mallinckrodt Critical Care · Aug 1977
UNIPAK CHOLESTEROL
K771093 · Harleco · Jul 1977
CHOLESTEROL PROCEDURE, TEKPOINT TOTAL
K770457 · Icn Pharmaceuticals, Inc. · May 1977