Cleared Traditional

K961953 - SAS SALMONELA H Z24 ANTISERUM

K961953 is the FDA 510(k) clearance for SAS SALMONELA H Z24 ANTISERUM by Sa Scientific, Inc.. It is a Class 2 Microbiology device (product code GRM) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K961953 · Sa Scientific, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1996
Decision
29d
Days
Class 2
Risk

K961953 is an FDA 510(k) clearance for the SAS SALMONELA H Z24 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 18, 1996 after a review of 29 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sa Scientific, Inc. devices

Submission Details

510(k) Number K961953 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1996
Decision Date June 18, 1996
Days to Decision 29 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
73d faster than avg
Panel avg: 102d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 65
Devices cleared under the same product code (GRM) and FDA review panel - the closest regulatory comparables to K961953.
SAS SALMONELLA O FACTOR 15 ANTISERUM &/OR O GROUP E2 FACTOR 15 ANTISERUM
K961950 · Sa Scientific, Inc. · Jun 1996
SAS SALMONELLA O FACTOR 6 ANTISERUM
K961951 · Sa Scientific, Inc. · Jun 1996
SAS SALMONELLA O FACTOR /O GROUP A FACTOR 2 ANTISERUMS
K961952 · Sa Scientific, Inc. · Jun 1996
SAS SALMONELLA H Z35 ANTISERUM
K961954 · Sa Scientific, Inc. · Jun 1996
SAS SALMONELLA H Z42 ANTISERUM
K961955 · Sa Scientific, Inc. · Jun 1996
SAS SALMONELLA H G,M,Q ANTISERMU
K961956 · Sa Scientific, Inc. · Jun 1996