Cleared Traditional

K843601 - ACCESS HEMAWIPE

K843601 is an FDA 510(k) clearance for ACCESS HEMAWIPE, manufactured by Medtech Products, Inc.. The device is a Class 2 Hematology device with product code KHE cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K843601 · Medtech Products, Inc. · Hematology device
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Jan 1985
Decision
114d
Days
Class 2
Risk

K843601 is an FDA 510(k) clearance for the ACCESS HEMAWIPE. Classified as Reagent, Occult Blood (product code KHE), Class II - Special Controls.

Submitted by Medtech Products, Inc. (Miami, US). The FDA issued a Cleared decision on January 4, 1985 after a review of 114 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Medtech Products, Inc. devices

FDA 510(k) Submission Details - K843601

510(k) Number K843601 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1984
Decision Date January 04, 1985
Days to Decision 114 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 113d · This submission: 114d
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 37
Devices cleared under the same product code (KHE) and FDA review panel - the closest regulatory comparables to K843601.
WAKO(TM) PRETEST 6A
K873409 · Wako Chemicals USA, Inc. · Feb 1988
HEMOCCULT WIPE TEST
K862849 · Smithkline Diagnostics, Inc. · Dec 1986
BIOTEL (TM)/ KIDNEY
K855237 · American Diagnostic Corp. · May 1986
UROPAPER EIKEN 8
K843532 · Syn-Kit, Inc. · Dec 1984
COLOSCREEN SELF-TEST
K843352 · Helena Laboratories · Dec 1984
HELENA COLOSCREEN SELF-TEST
K840903 · Helena Laboratories · Aug 1984