Cleared Traditional

K820072 - FE-CULT PLUS

K820072 is the FDA 510(k) clearance for FE-CULT PLUS by Gamma Biologicals, Inc.. It is a Class 2 Hematology device (product code KHE) cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K820072 · Gamma Biologicals, Inc. · Hematology device
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Mar 1982
Decision
51d
Days
Class 2
Risk

K820072 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. (Walker, US). The FDA issued a Cleared decision on March 4, 1982 after a review of 51 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.6550 - 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 Gamma Biologicals, Inc. devices

Submission Details

510(k) Number K820072 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 1982
Decision Date March 04, 1982
Days to Decision 51 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 113d · This submission: 51d
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 Hematology 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 K820072.
HELENA BIO STRIP OB
K834456 · Helena Laboratories · Jan 1984
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