Cleared Traditional

K934323 - DRIED GRAM-POSITIVE MIC/COMBO PANELS

K934323 is the FDA 510(k) clearance for DRIED GRAM-POSITIVE MIC/COMBO PANELS by Baxter Diagnostics, Inc.. It is a Class 2 Microbiology device (product code JWY) cleared through the Traditional 510(k) pathway after a 411-day FDA review.

K934323 · Baxter Diagnostics, Inc. · Microbiology device
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Oct 1994
Decision
411d
Days
Class 2
Risk

K934323 is an FDA 510(k) clearance for the DRIED GRAM-POSITIVE MIC/COMBO PANELS, AMP/EXT DIL. Classified as Manual Antimicrobial Susceptibility Test Systems (product code JWY), Class II - Special Controls.

Submitted by Baxter Diagnostics, Inc. (West Sacramento, US). The FDA issued a Cleared decision on October 19, 1994 after a review of 411 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Microbiology submissions.

View all Baxter Diagnostics, Inc. devices

Submission Details

510(k) Number K934323 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1993
Decision Date October 19, 1994
Days to Decision 411 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
309d slower than avg
Panel avg: 102d · This submission: 411d
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 K934323.
DRIED GRAM-POSITIVE MIC/COMBO PANELS/CEFMETAZOLE
K942267 · Baxter Diagnostics, Inc. · Jan 1995
DRIED GRAM-POSITIVE MIC/COMBO PANELS
K943510 · Baxter Diagnostics, Inc. · Dec 1994
DRIED GRAM-POSITIVE MIC/COMBO PANELS
K944651 · Baxter Diagnostics, Inc. · Nov 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
K933709 · Pasco Laboratories, Inc. · Dec 1993