Cleared Traditional

K983408 - DRIED GRAM-NEGATIVE AND GRAM-POSITIVE M...

K983408 is the FDA 510(k) clearance for DRIED GRAM-NEGATIVE AND GRAM-POSITIVE M... by Dade Microscan, Inc.. It is a Class 2 Microbiology device (product code JWY) cleared through the Traditional 510(k) pathway after a 224-day FDA review.

K983408 · Dade Microscan, Inc. · Microbiology device
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May 1999
Decision
224d
Days
Class 2
Risk

K983408 is an FDA 510(k) clearance for the DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS. Classified as Manual Antimicrobial Susceptibility Test Systems (product code JWY), Class II - Special Controls.

Submitted by Dade Microscan, Inc. (West Sacramento, US). The FDA issued a Cleared decision on May 10, 1999 after a review of 224 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 Dade Microscan, Inc. devices

Submission Details

510(k) Number K983408 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1998
Decision Date May 10, 1999
Days to Decision 224 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
122d slower than avg
Panel avg: 102d · This submission: 224d
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 K983408.
PASCO MIC AND MIC/ID PANELS
K992059 · Pasco Laboratories, Inc. · Aug 1999
PASCO MIC AND MIC/ID PANELS
K991925 · Pasco Laboratories, Inc. · Aug 1999
DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS
K983922 · Dade Microscan, Inc. · Jun 1999
DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS
K983711 · Dade Microscan, Inc. · Apr 1999
ETEST FOR CEFUROXIME
K990722 · Ab Biodisk · Apr 1999
TRIMETHOPRIM/SULPHAMETHOXAZOLE (1/19)
K990685 · Ab Biodisk · Mar 1999