Cleared Traditional

K912924 - RAMBACH AGAR

K912924 is the FDA 510(k) clearance for RAMBACH AGAR by Rantran, Inc.. It is a Class 1 Microbiology device (product code JSS) cleared through the Traditional 510(k) pathway after a 240-day FDA review.

K912924 · Rantran, Inc. · Microbiology device
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Feb 1992
Decision
240d
Days
Class 1
Risk

K912924 is an FDA 510(k) clearance for the RAMBACH AGAR. Classified as Kit, Identification, Enterobacteriaceae (product code JSS), Class I - General Controls.

Submitted by Rantran, Inc. (Ashland, US). The FDA issued a Cleared decision on February 28, 1992 after a review of 240 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2660 - 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 Rantran, Inc. devices

Submission Details

510(k) Number K912924 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 1991
Decision Date February 28, 1992
Days to Decision 240 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
138d slower than avg
Panel avg: 102d · This submission: 240d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSS Kit, Identification, Enterobacteriaceae
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JSS Kit, Identification, Enterobacteriaceae

All 9
Devices cleared under the same product code (JSS) and FDA review panel - the closest regulatory comparables to K912924.
ROCHE ENTEROTUBE II
K922588 · Roche Diagnostic Systems, Inc. · Sep 1992
GI MOTILITY TEST MEDIUM W/TTC
K863603 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1986
COBAS BACT ID TEST SYS, INDOLE SPOT TEST REAGENT
K853009 · Roche Diagnostic Systems, Inc. · Mar 1986
QUANTUM II BACTERIAL IDENT. SYSTEM
K830698 · Abbott Laboratories · Apr 1983
UREA-PDA DISK
K830396 · Remel Co. · Mar 1983
MINITECK ENTERIC BROTH & ENTEROBACTER
K812286 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1981