Cleared Traditional

K853278 - POLIO TYPE I CF ANTIGEN, & TYPE II, III

K853278 is an FDA 510(k) clearance for POLIO TYPE I CF ANTIGEN, manufactured by Hillcrest Biologicals. The device is a Class 1 Microbiology device with product code GOG cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K853278 · Hillcrest Biologicals · Microbiology device
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Nov 1985
Decision
94d
Days
Class 1
Risk

K853278 is an FDA 510(k) clearance for the POLIO TYPE I CF ANTIGEN, & TYPE II, III. Classified as Antisera, Cf, Poliovirus 1-3 (product code GOG), Class I - General Controls.

Submitted by Hillcrest Biologicals (Cypress, US). The FDA issued a Cleared decision on November 7, 1985 after a review of 94 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3405 - 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 - K853278

510(k) Number K853278 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1985
Decision Date November 07, 1985
Days to Decision 94 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
8d faster than avg
Panel avg: 102d · This submission: 94d
Pathway characteristics
Predicate-based equivalence.

GOG Device Classification - Class 1, General Controls

Product Code GOG Antisera, Cf, Poliovirus 1-3
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3405
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.