Cleared Traditional

K960609 - SAS SALMONELLA H Z32 ANTISERUM

K960609 is the FDA 510(k) clearance for SAS SALMONELLA H Z32 ANTISERUM by Sa Scientific, Inc.. It is a Class 2 Microbiology device (product code GRM) cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K960609 · Sa Scientific, Inc. · Microbiology device
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Mar 1996
Decision
20d
Days
Class 2
Risk

K960609 is an FDA 510(k) clearance for the SAS SALMONELLA H Z32 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 March 4, 1996 after a review of 20 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 K960609 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 1996
Decision Date March 04, 1996
Days to Decision 20 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
82d faster than avg
Panel avg: 102d · This submission: 20d
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 K960609.
SAS SALMONELLA H G,P,U ANTISERUM
K960333 · Sa Scientific, Inc. · Mar 1996
SAS SALMONELLA H POLY A-Z ANTISERUM
K960335 · Sa Scientific, Inc. · Mar 1996
SAS SALMONELLA H Z23 ANTISERUM
K960603 · Sa Scientific, Inc. · Mar 1996
SAS SALMONELLA H Z15 ANTISERUM
K960610 · Sa Scientific, Inc. · Mar 1996
SAS SPICER-EDWARDS 1 COMPLEX
K955222 · Sa Scientific, Inc. · Feb 1996
SAS SALMONELLA H C ANTISERUM
K952288 · Sa Scientific, Inc. · Jul 1995