Cleared Traditional

K910438 - DIPSTICK SALMONELLA

K910438 is an FDA 510(k) clearance for DIPSTICK SALMONELLA, manufactured by Ampcor, Inc.. The device is a Class 2 Microbiology device with product code GRM cleared through the Traditional 510(k) pathway after a 225-day FDA review.

K910438 · Ampcor, Inc. · Microbiology device
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Sep 1991
Decision
225d
Days
Class 2
Risk

K910438 is an FDA 510(k) clearance for the DIPSTICK SALMONELLA. Classified as Antisera, All Groups, Salmonella Spp. (product code GRM), Class II - Special Controls.

Submitted by Ampcor, Inc. (Bridgeport, US). The FDA issued a Cleared decision on September 13, 1991 after a review of 225 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3550 - 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 Ampcor, Inc. devices

FDA 510(k) Submission Details - K910438

510(k) Number K910438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 1991
Decision Date September 13, 1991
Days to Decision 225 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
123d slower than avg
Panel avg: 102d · This submission: 225d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GRM Device Classification - Class 2, Special Controls

Product Code GRM Antisera, All Groups, Salmonella Spp.
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3550
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 - GRM Antisera, All Groups, Salmonella Spp.

All 67
Devices cleared under the same product code (GRM) and FDA review panel - the closest regulatory comparables to K910438.
SAS SALMONELLA H POLY POSITIVE ANTISERUM
K952134 · Sa Scientific, Inc. · Jul 1995
SAS SALMONELLA H B ANTISERUM
K951069 · Sa Scientific, Inc. · Jun 1995
SAS SALMONELLA H D ANTISERUM
K943400 · Sa Scientific, Inc. · Nov 1994
WELLCOLEX COLOUR SALMONELLA TEST ZL 50
K890146 · Wellcome Diagnostics · Feb 1989
BACTIGEN SALMONELLA-SHIGELLA TEST
K870813 · Armkel, LLC · Apr 1987
SALMONELLA I.D.
K821338 · Analytical Products, Inc. · May 1982