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Sas Salmonella H L, V Antiserum

FDA 510(k)

Class II (US FDA 510(k))

510(k) K955205

by Sa Scientific, Inc.

Identifiers

510(k) Number
K955205 FDA 510(k)
FDA Product Code
GNC 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)

The Sas Salmonella H L, V Antiserum is an antigen used in the diagnosis of salmonellosis, a disease caused by bacteria belonging to the genus Salmonella. It provides epidemiological information on this disease, which is characterized by high-grade fever, severe diarrhea, and cramps. The device is classified as a Class II device with special controls.

The Sas Salmonella H L, V Antiserum is supplied with an FDA 510K authorization, specifically clearance K955205, and is classified under product code GNC. It is used in the field of microbiology and has a registration number. The device is intended to aid in the diagnosis of salmonellosis and is used in laboratory settings.

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 L,V ANTISERUM by SA SCIENTIFIC, INC. | FDA 510 (k) Summary, SAS SALMONELLA H L,V ANTISERUM - fda.innolitics.com, SAS SALMONELLA H L,V ANTISERUM (K955205) - FDA 510 (k), PDF K955205 - SAS SALMONELLA H L,V ANTISERUM - 510kdatabase.net, SAS SALMONELLA H F ANTISERUM (K960133) — FDA 510(k) | Innolitics

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) K955205 24 fields · synced Sep 27, 2026