Cleared Traditional

K820996 - SALMONELLA & SHIGELLA GROUPING SERA (FDA 510(k) Clearance)

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K820996 · Fisher Scientific Co., LLC · Microbiology device
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May 1982
Decision
24d
Days
Class 2
Risk

K820996 is an FDA 510(k) clearance for the SALMONELLA & SHIGELLA GROUPING SERA. Classified as Antigens, All Groups, Salmonella Spp. (product code GRL), Class II - Special Controls.

Submitted by Fisher Scientific Co., LLC (Mchenry, US). The FDA issued a Cleared decision on May 3, 1982 after a review of 24 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 Fisher Scientific Co., LLC devices

Submission Details

510(k) Number K820996 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 1982
Decision Date May 03, 1982
Days to Decision 24 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 102d · This submission: 24d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GRL Antigens, 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.