Cleared Traditional

K935805 - PASCO MIC AND MIC/ID PANELS

K935805 is an FDA 510(k) clearance for PASCO MIC AND MIC/ID PANELS, manufactured by Pasco Laboratories, Inc.. The device is a Class 2 Microbiology device with product code JTT cleared through the Traditional 510(k) pathway after a 193-day FDA review.

K935805 · Pasco Laboratories, Inc. · Microbiology device
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Optimized for regulatory review, auditing and printing
Jun 1994
Decision
193d
Days
Class 2
Risk

K935805 is an FDA 510(k) clearance for the PASCO MIC AND MIC/ID PANELS. Classified as Susceptibility Test Powders, Antimicrobial (product code JTT), Class II - Special Controls.

Submitted by Pasco Laboratories, Inc. (Wheat Ridge, US). The FDA issued a Cleared decision on June 13, 1994 after a review of 193 days - an extended review 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: 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 Pasco Laboratories, Inc. devices

FDA 510(k) Submission Details - K935805

510(k) Number K935805 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 1993
Decision Date June 13, 1994
Days to Decision 193 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
91d slower than avg
Panel avg: 102d · This submission: 193d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JTT Device Classification - Class 2, Special Controls

Product Code JTT Susceptibility Test Powders, Antimicrobial
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 - JTT Susceptibility Test Powders, Antimicrobial

All 7
Devices cleared under the same product code (JTT) and FDA review panel - the closest regulatory comparables to K935805.
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IMIPENEM 10 MCG SENSITIVITY DISCS
K855207 · Difco Laboratories, Inc. · Mar 1986
GEN DIAGNOSTICS' IMIPENEM 10 MCG SUSCEPTIBITY DISK
K860031 · Organon Teknika Corp. · Mar 1986
AZLIN AZLOCILIN SODIUM-DIAG. REAGENT
K830758 · Miles Laboratories, Inc. · May 1983