Cleared Traditional

K822095 - HERPES-IHA KIT (FDA 510(k) Clearance)

Class I Microbiology device.

K822095 · Hillcrest Biologicals · Microbiology device
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Apr 1983
Decision
263d
Days
Class 1
Risk

K822095 is an FDA 510(k) clearance for the HERPES-IHA KIT. Classified as Chair, Dental, With Operative Unit (product code KLC), Class I - General Controls.

Submitted by Hillcrest Biologicals (Mchenry, US). The FDA issued a Cleared decision on April 5, 1983 after a review of 263 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 872.6250 - the FDA microbiology 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 Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Hillcrest Biologicals devices

Submission Details

510(k) Number K822095 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 1982
Decision Date April 05, 1983
Days to Decision 263 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
161d slower than avg
Panel avg: 102d · This submission: 263d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KLC Chair, Dental, With Operative Unit
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6250
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.