Cleared Traditional

K951069 - SAS SALMONELLA H B ANTISERUM

K951069 is an FDA 510(k) clearance for SAS SALMONELLA H B ANTISERUM, manufactured by Sa Scientific, Inc.. The device is a Class 2 Microbiology device with product code GRM cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K951069 · Sa Scientific, Inc. · Microbiology device
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Jun 1995
Decision
93d
Days
Class 2
Risk

K951069 is an FDA 510(k) clearance for the SAS SALMONELLA H B ANTISERUM. Classified as Antisera, All Groups, Salmonella Spp. (product code GRM), Class II - Special Controls.

Submitted by Sa Scientific, Inc. (San Antonio, US). The FDA issued a Cleared decision on June 9, 1995 after a review of 93 days - within the typical 510(k) review window.

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 Sa Scientific, Inc. devices

FDA 510(k) Submission Details - K951069

510(k) Number K951069 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1995
Decision Date June 09, 1995
Days to Decision 93 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
9d faster than avg
Panel avg: 102d · This submission: 93d
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 66
Devices cleared under the same product code (GRM) and FDA review panel - the closest regulatory comparables to K951069.
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