Cleared Traditional

K811752 - FE-CULT PLUS

K811752 is the FDA 510(k) clearance for FE-CULT PLUS by Gamma Biologicals, Inc.. It is a Class 2 Toxicology device (product code KHE) cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K811752 · Gamma Biologicals, Inc. · Toxicology device
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Nov 1981
Decision
133d
Days
Class 2
Risk

K811752 is an FDA 510(k) clearance for the FE-CULT PLUS. Classified as Reagent, Occult Blood (product code KHE), Class II - Special Controls.

Submitted by Gamma Biologicals, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 2, 1981 after a review of 133 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 864.6550 - the FDA toxicology 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Gamma Biologicals, Inc. devices

Submission Details

510(k) Number K811752 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1981
Decision Date November 02, 1981
Days to Decision 133 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d slower than avg
Panel avg: 87d · This submission: 133d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KHE Reagent, Occult Blood
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.6550
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 Toxicology devices follow this clearance model.

Regulatory Peers - KHE Reagent, Occult Blood

All 30
Devices cleared under the same product code (KHE) and FDA review panel - the closest regulatory comparables to K811752.
COLOSCREEN V.P.I.
K832864 · Helena Laboratories · Nov 1983
GASTROCCULT TM
K821884 · Smithkline Diagnostics, Inc. · Oct 1982
UROPAPER EIKEG
K811815 · Syn-Kit, Inc. · Dec 1981
HELENA COLOSCREEN METHOD
K812428 · Helena Laboratories · Oct 1981
HELENA COLOCHECK
K800433 · Helena Laboratories · May 1980
HELENA COLOSCREEN
K792655 · Helena Laboratories · Jan 1980