Cleared Traditional

K912964 - API UNISCEPT MIC/UNISCEPT MICRO-MIC

K912964 is the FDA 510(k) clearance for API UNISCEPT MIC/UNISCEPT MICRO-MIC by Analytab Products, Inc.. It is a Class 2 Microbiology device (product code JWY) cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K912964 · Analytab Products, Inc. · Microbiology device
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Aug 1991
Decision
52d
Days
Class 2
Risk

K912964 is an FDA 510(k) clearance for the API UNISCEPT MIC/UNISCEPT MICRO-MIC. Classified as Manual Antimicrobial Susceptibility Test Systems (product code JWY), Class II - Special Controls.

Submitted by Analytab Products, Inc. (Plainveiw, US). The FDA issued a Cleared decision on August 29, 1991 after a review of 52 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1640 - 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: 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 Analytab Products, Inc. devices

Submission Details

510(k) Number K912964 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1991
Decision Date August 29, 1991
Days to Decision 52 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 102d · This submission: 52d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JWY Manual Antimicrobial Susceptibility Test Systems
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1640
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 Microbiology devices follow this clearance model.

Regulatory Peers - JWY Manual Antimicrobial Susceptibility Test Systems

All 365
Devices cleared under the same product code (JWY) and FDA review panel - the closest regulatory comparables to K912964.
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