Cleared Traditional

K934380 - PASCO MIC PANELS/ GENT & STREP SYNERGY

K934380 is an FDA 510(k) clearance for PASCO MIC PANELS/ GENT & STREP SYNERGY, manufactured by Pasco Laboratories, Inc.. The device is a Class 2 Microbiology device with product code JWY cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K934380 · Pasco Laboratories, Inc. · Microbiology device
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Jan 1994
Decision
141d
Days
Class 2
Risk

K934380 is an FDA 510(k) clearance for the PASCO MIC PANELS/ GENT & STREP SYNERGY. 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 January 27, 1994 after a review of 141 days - within the typical 510(k) review window.

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 - K934380

510(k) Number K934380 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 1993
Decision Date January 27, 1994
Days to Decision 141 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
39d slower than avg
Panel avg: 102d · This submission: 141d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JWY Device Classification - Class 2, Special Controls

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 405
Devices cleared under the same product code (JWY) and FDA review panel - the closest regulatory comparables to K934380.
DRIED GRAM-POSITIVE MIC/COMBO PANELS
K944651 · Baxter Diagnostics, Inc. · Nov 1994
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 AND MIC/ID PANELS
K933709 · Pasco Laboratories, Inc. · Dec 1993
PASCO MIC AND MIC/ID PANELS
K933746 · Pasco Laboratories, Inc. · Dec 1993
PASCO MIC AND MIC/ID PANELS
K933849 · Pasco Laboratories, Inc. · Nov 1993