Cleared Traditional

K941443 - SYNERGY QUAD

K941443 is an FDA 510(k) clearance for SYNERGY QUAD, manufactured by Remel Co.. The device is a Class 2 Microbiology device with product code JSO cleared through the Traditional 510(k) pathway after a 179-day FDA review.

K941443 · Remel Co. · Microbiology device
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Sep 1994
Decision
179d
Days
Class 2
Risk

K941443 is an FDA 510(k) clearance for the SYNERGY QUAD. Classified as Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar (product code JSO), Class II - Special Controls.

Submitted by Remel Co. (Lenexa, US). The FDA issued a Cleared decision on September 19, 1994 after a review of 179 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1700 - 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 Remel Co. devices

FDA 510(k) Submission Details - K941443

510(k) Number K941443 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1994
Decision Date September 19, 1994
Days to Decision 179 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
77d slower than avg
Panel avg: 102d · This submission: 179d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JSO Device Classification - Class 2, Special Controls

Product Code JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1700
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 - JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar

All 37
Devices cleared under the same product code (JSO) and FDA review panel - the closest regulatory comparables to K941443.
CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST
K951754 · Hardy Diagnostics · Oct 1995
GCII AGAR WITH ISOVITALX(R) ENRICHMENT
K945569 · Becton Dickinson Microbiology Systems · Feb 1995
BRAIN HEART INFUSION AGAR
K944554 · Carr-Scarborough Microbiologicals, Inc. · Oct 1994
BHI AGAR WITH VANCOMYCIN
K941444 · Remel Co. · Sep 1994
GC II AGAR WITH ISOVITALEX
K932882 · Becton Dickinson Microbiology Systems · Sep 1993
G C II AGAR WITH SENSIVITALEX
K932879 · Becton Dickinson Microbiology Systems · Sep 1993