Cleared Traditional

K943510 - DRIED GRAM-POSITIVE MIC/COMBO PANELS

K943510 is an FDA 510(k) clearance for DRIED GRAM-POSITIVE MIC/COMBO PANELS, manufactured by Baxter Diagnostics, Inc.. The device is a Class 2 Microbiology device with product code JWY cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K943510 · Baxter Diagnostics, Inc. · Microbiology device
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Dec 1994
Decision
135d
Days
Class 2
Risk

K943510 is an FDA 510(k) clearance for the DRIED GRAM-POSITIVE MIC/COMBO PANELS. Classified as Manual Antimicrobial Susceptibility Test Systems (product code JWY), Class II - Special Controls.

Submitted by Baxter Diagnostics, Inc. (Mcgaw Park, US). The FDA issued a Cleared decision on December 2, 1994 after a review of 135 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 Baxter Diagnostics, Inc. devices

FDA 510(k) Submission Details - K943510

510(k) Number K943510 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1994
Decision Date December 02, 1994
Days to Decision 135 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
33d slower than avg
Panel avg: 102d · This submission: 135d
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 404
Devices cleared under the same product code (JWY) and FDA review panel - the closest regulatory comparables to K943510.
PASCO MIC AND MIC/ID PANELS
K946126 · Pasco Laboratories, Inc. · Jan 1995
MICRODILUTION/LORACARBEF PANELS
K942089 · Baxter Diagnostics, Inc. · Jan 1995
DRIED GRAM-POSITIVE MIC/COMBO PANELS/CEFMETAZOLE
K942267 · Baxter Diagnostics, Inc. · Jan 1995
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