Cleared Traditional

K801425 - RH CONTROL

K801425 is the FDA 510(k) clearance for RH CONTROL by North American Biologicals, Inc.. It is a Class 2 Hematology device (product code KSF) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K801425 · North American Biologicals, Inc. · Hematology device
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Jul 1980
Decision
27d
Days
Class 2
Risk

K801425 is an FDA 510(k) clearance for the RH CONTROL. Classified as Kit, Quality Control For Blood Banking Reagents (product code KSF), Class II - Special Controls.

Submitted by North American Biologicals, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 14, 1980 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.9650 - 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 North American Biologicals, Inc. devices

Submission Details

510(k) Number K801425 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1980
Decision Date July 14, 1980
Days to Decision 27 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 113d · This submission: 27d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KSF Kit, Quality Control For Blood Banking Reagents
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.9650
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 - KSF Kit, Quality Control For Blood Banking Reagents

Devices cleared under the same product code (KSF) and FDA review panel - the closest regulatory comparables to K801425.
AVI-D CONTROL
K811713 · Ortho Diagnostic Systems, Inc. · Oct 1981
DADE RH CONTROL REAGENT
K810599 · American Dade · Mar 1981
TEST CELLS
K790249 · Hyland Therapeutic Div., Travenol Laboratories · May 1979
QUALITY CONTROL SYSTEM, SPECTRA
K780097 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1978
UNIVAL CONTROL CELLS
K761284 · Dade, Baxter Travenol Diagnostics, Inc. · Jan 1977