Cleared Traditional

K936056 - HEMDETECT(R) TEST FOR OCCULT BLOOD IN FECES

K936056 is an FDA 510(k) clearance for HEMDETECT TEST FOR OCCULT BLOOD IN FECES, manufactured by Dipro Diagnostic Products GmbH. The device is a Class 2 Hematology device with product code KHE cleared through the Traditional 510(k) pathway after a 471-day FDA review.

K936056 · Dipro Diagnostic Products GmbH · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1995
Decision
471d
Days
Class 2
Risk

K936056 is an FDA 510(k) clearance for the HEMDETECT(R) TEST FOR OCCULT BLOOD IN FECES. Classified as Reagent, Occult Blood (product code KHE), Class II - Special Controls.

Submitted by Dipro Diagnostic Products GmbH (Mamaroneck, US). The FDA issued a Cleared decision on April 5, 1995 after a review of 471 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Hematology submissions.

View all Dipro Diagnostic Products GmbH devices

FDA 510(k) Submission Details - K936056

510(k) Number K936056 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1993
Decision Date April 05, 1995
Days to Decision 471 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
358d slower than avg
Panel avg: 113d · This submission: 471d
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 Hematology devices follow this clearance model.

Regulatory Peers - KHE Reagent, Occult Blood

All 62
Devices cleared under the same product code (KHE) and FDA review panel - the closest regulatory comparables to K936056.
COLOSCREEN-ES
K980671 · Helena Laboratories · May 1998
HEMAPROMPT
K972763 · Aerscher Diagnostics · Oct 1997
FLEXSURE OBT
K961062 · Smithkline Diagnostics, Inc. · Nov 1996
PROPPER SUPER SERACULT(R)
K921798 · Propper Mfg. Co., Inc. · Oct 1992
HEMAWIPE SYSTEM, THE CIVILIZED TEST, MODIFICATION
K912979 · Labeltape Meditect, Inc. · Oct 1991
COLOCARE
K905798 · Helena Laboratories · Jul 1991