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FDA 510(k)

SAS FEBRILE POSITIVE & NEGATIVE CONTROL ANTISERUM

K-Number: K952145 · 1995-07-18

ApplicantSa Scientific, Inc.
Decision Date1995-07-18
Product CodeGSN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SAS FEBRILE POSITIVE & NEGATIVE CONTROL ANTISERUM is the device name listed in this FDA 510(k) record. The listed applicant is Sa Scientific, Inc.. It received FDA 510(k) clearance on 1995-07-18 under 510(k) number K952145. The device is classified under product code GSN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAS FEBRILE POSITIVE & NEGATIVE CONTROL ANTISERUM?

SAS FEBRILE POSITIVE & NEGATIVE CONTROL ANTISERUM is a medical device that received FDA 510(k) clearance on 1995-07-18. The listed applicant is Sa Scientific, Inc.. The 510(k) number is K952145.

When did SAS FEBRILE POSITIVE & NEGATIVE CONTROL ANTISERUM receive FDA 510(k) clearance?

SAS FEBRILE POSITIVE & NEGATIVE CONTROL ANTISERUM received FDA 510(k) clearance on 1995-07-18, under 510(k) number K952145.

Who is the listed applicant for SAS FEBRILE POSITIVE & NEGATIVE CONTROL ANTISERUM?

The FDA 510(k) record lists Sa Scientific, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SAS FEBRILE POSITIVE & NEGATIVE CONTROL ANTISERUM?

The FDA product code for SAS FEBRILE POSITIVE & NEGATIVE CONTROL ANTISERUM is GSN.

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Other records listing Sa Scientific, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K100227SAS FLUALERT A&B, SAS INFLUENZA A TESTK080380SAS INFLUENZA A & B TESTK041439SAS INFLUENZA B TESTK041441SAS INFLUENZA A TESTK030628SAS RSV CONTROL KITK022845SAS RSV TEST

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Related Devices (Code: GSN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K885113IFA* POSITIVE AND NEGATIVE ANTIGENS CONTROLInvestigacion Farmaceutica S.A. DE C.V.K791385NEGATIVE CONTROL SERUM FOR CF RO IDImmuno-Mycologics, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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