Cleared Traditional

K822095 - HERPES-IHA KIT

K822095 is an FDA 510(k) clearance for HERPES-IHA KIT, manufactured by Hillcrest Biologicals. The device is a Class 1 Microbiology device with product code KLC cleared through the Traditional 510(k) pathway after a 263-day FDA review.

K822095 · Hillcrest Biologicals · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K822095

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
161d slower than avg
Panel avg: 102d · This submission: 263d
Pathway characteristics
Predicate-based equivalence.

KLC Device Classification - Class 1, General Controls

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.