Cleared Traditional

K933709 - PASCO MIC AND MIC/ID PANELS

K933709 is the FDA 510(k) clearance for PASCO MIC AND MIC/ID PANELS by Pasco Laboratories, Inc.. It is a Class 2 Microbiology device (product code JWY) cleared through the Traditional 510(k) pathway after a 150-day FDA review.

K933709 · Pasco Laboratories, Inc. · Microbiology device
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Dec 1993
Decision
150d
Days
Class 2
Risk

K933709 is an FDA 510(k) clearance for the PASCO MIC AND MIC/ID PANELS. Classified as Manual Antimicrobial Susceptibility Test Systems (product code JWY), Class II - Special Controls.

Submitted by Pasco Laboratories, Inc. (Wheat Ridge, US). The FDA issued a Cleared decision on December 27, 1993 after a review of 150 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

Submission Details

510(k) Number K933709 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 1993
Decision Date December 27, 1993
Days to Decision 150 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
48d slower than avg
Panel avg: 102d · This submission: 150d
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 360
Devices cleared under the same product code (JWY) and FDA review panel - the closest regulatory comparables to K933709.
DRIED GRAM-POSITIVE MIC/COMBO PANELS, AMP/EXT DIL
K934323 · Baxter Diagnostics, Inc. · Oct 1994
PASCO MIC AND MIC/ID PANELS
K944517 · Pasco Laboratories, Inc. · Oct 1994
PASCO MIC PANELS/ GENT & STREP SYNERGY
K934380 · Pasco Laboratories, Inc. · Jan 1994
PASCO MIC AND MIC/ID PANELS
K933746 · Pasco Laboratories, Inc. · Dec 1993
PASCO MIC AND MIC/ID PANELS
K933849 · Pasco Laboratories, Inc. · Nov 1993
PASCO MIC AND MIC/ID PANELS
K932917 · Pasco Laboratories, Inc. · Aug 1993