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SAS Salmonella H F Antiserum

FDA 510(k)

Class II (US FDA 510(k))

510(k) K960133

by Sa Scientific, Inc.

Identifiers

510(k) Number
K960133 FDA 510(k)
FDA Product Code
GRM FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.3550 FDA 510(k)
Regulation Number
866.3550 FDA 510(k)
Advisory Committee
Microbiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

SAS Salmonella H F Antiserum is a diagnostic reagent used in microbiology to identify Salmonella species. It is classified as an antisera product intended for serological testing.

The device is supplied as a serum and is intended for single-use applications. It is not sterilized and requires proper storage conditions. The product is regulated under FDA 510(k) clearance K960133.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: SAS SALMONELLA H F ANTISERUM (K960133) — FDA 510(k) | Innolitics, SAS SALMONELLA H F ANTISERUM 510 (k) K960133 - FDA.report, SAS SALMONELLA H F,G, ANTISERUM (K955210) - FDA 510 (k), PDF K960133 - Sas Salmonella H F Antiserum

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Sa Scientific, Inc.

Sources (1)

  • FDA 510(k) K960133 24 fields · synced Sep 21, 2026