Cleared Traditional

K811752 - FE-CULT PLUS

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

K811752 · Gamma Biologicals, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K811752

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
Combination Product No
PCCP Authorized No
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.

KHE Device Classification - Class 2, Special Controls

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 59
Devices cleared under the same product code (KHE) and FDA review panel - the closest regulatory comparables to K811752.
FE-CULT PLUS
K820072 · Gamma Biologicals, Inc. · Mar 1982
SERACULT OCCULT BLOOF TEST
K813204 · Propper Mfg. Co., Inc. · Jan 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