Cleared Traditional

K980342 - ETEST CHLORAMPHENICAL

K980342 is an FDA 510(k) clearance for ETEST CHLORAMPHENICAL, manufactured by Ab Biodisk. The device is a Class 2 Microbiology device with product code JWY cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K980342 · Ab Biodisk · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1998
Decision
121d
Days
Class 2
Risk

K980342 is an FDA 510(k) clearance for the ETEST CHLORAMPHENICAL. Classified as Manual Antimicrobial Susceptibility Test Systems (product code JWY), Class II - Special Controls.

Submitted by Ab Biodisk (Solna, SE). The FDA issued a Cleared decision on May 29, 1998 after a review of 121 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 Ab Biodisk devices

FDA 510(k) Submission Details - K980342

510(k) Number K980342 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 1998
Decision Date May 29, 1998
Days to Decision 121 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
19d slower than avg
Panel avg: 102d · This submission: 121d
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 K980342.
ETEST CEFOTAXIME
K981137 · Ab Biodisk · Jun 1998
ETEST CIPROFLOXACIN
K981138 · Ab Biodisk · Jun 1998
ETEST CEFTRIAXONE
K981139 · Ab Biodisk · Jun 1998
ETEST VANCOMYCIN
K980348 · Ab Biodisk · May 1998
ETEST OFLOXACIN
K980338 · Ab Biodisk · May 1998
ETEST TETRACYCLINE
K981134 · Ab Biodisk · May 1998