Cleared Traditional

K843250 - BHK-21

K843250 is the FDA 510(k) clearance for BHK-21 by Viromed Laboratories, Inc.. It is a Class 1 Pathology device (product code KIR) cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K843250 · Viromed Laboratories, Inc. · Pathology device
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Sep 1984
Decision
17d
Days
Class 1
Risk

K843250 is an FDA 510(k) clearance for the BHK-21. Classified as Cells, Animal And Human, Cultured (product code KIR), Class I - General Controls.

Submitted by Viromed Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 6, 1984 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.2280 - the FDA pathology 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 Viromed Laboratories, Inc. devices

Submission Details

510(k) Number K843250 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1984
Decision Date September 06, 1984
Days to Decision 17 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 77d · This submission: 17d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KIR Cells, Animal And Human, Cultured
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.2280
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KIR Cells, Animal And Human, Cultured

All 80
Devices cleared under the same product code (KIR) and FDA review panel - the closest regulatory comparables to K843250.
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K842000 · Bartels Immunodiagnostic Supplies, Inc. · Jun 1984