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Sas Salmonella 0 Factor 8 Antiserum And/Or Sas Salmonella 0 Group C2 Factor 9 Antiserum

FDA 510(k)

Class II (US FDA 510(k))

510(k) K960138

by Sa Scientific, Inc.

Identifiers

510(k) Number
K960138 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)

The Sas Salmonella 0 Factor 8 Antiserum And/Or Sas Salmonella 0 Group C2 Factor 9 Antiserum is an antisera device. It is classified as a device in the medical specialty of Microbiology. The device is used in the context of microbiology.

The device has FDA 510K clearance, with the clearance number K960138. It is supplied by Sa Scientific, Inc. and is classified as a device with a product code of GRM and a regulation number of 866.3550. The device is intended for use in microbiology applications.

Frequently asked questions

What is the Sas Salmonella 0 Factor 8 Antiserum used for?

The Sas Salmonella 0 Factor 8 Antiserum is used in microbiology applications, specifically for identifying Salmonella species.

Is the Sas Salmonella 0 Factor 8 Antiserum supplied sterile?

The device data does not explicitly state that the Sas Salmonella 0 Factor 8 Antiserum is supplied sterile, so its sterility should be verified before use.

What is the regulatory classification of the Sas Salmonella 0 Factor 8 Antiserum?

The Sas Salmonella 0 Factor 8 Antiserum has a product code of GRM and a regulation number of 866.3550, indicating its classification as a device in the medical specialty of Microbiology.

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 0 Factor 8 Antiserum And/Or Sas Salmonella 0 Group C2 ..., K960138 FDA 510(k) - SAS SALMONELLA 0 FACTOR 8 ANTISERUM AND..., Sas Salmonella 0 Factor 8 Antiserum And/or Sas Salmonella 0 Group C2 ..., PDF K960138 - Sas Salmonella 0 Factor 8 Antiserum And/Or Sas Salmonella 0 ..., Sas Salmonella 0 Factor 8 Antiserum And/Or Sas Salmonella 0 Group C2 ...

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) K960138 24 fields · synced Sep 22, 2026