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FDA 510(k)

VISTA ANTIGEN BRUCELLA MELITENSIS

K-Number: K972396 · 1997-08-25

ApplicantLee Laboratories, Inc.
Decision Date1997-08-25
Product CodeGSO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

VISTA ANTIGEN BRUCELLA MELITENSIS is the device name listed in this FDA 510(k) record. The listed applicant is Lee Laboratories, Inc.. It received FDA 510(k) clearance on 1997-08-25 under 510(k) number K972396. The device is classified under product code GSO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VISTA ANTIGEN BRUCELLA MELITENSIS?

VISTA ANTIGEN BRUCELLA MELITENSIS is a medical device that received FDA 510(k) clearance on 1997-08-25. The listed applicant is Lee Laboratories, Inc.. The 510(k) number is K972396.

When did VISTA ANTIGEN BRUCELLA MELITENSIS receive FDA 510(k) clearance?

VISTA ANTIGEN BRUCELLA MELITENSIS received FDA 510(k) clearance on 1997-08-25, under 510(k) number K972396.

Who is the listed applicant for VISTA ANTIGEN BRUCELLA MELITENSIS?

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

What is the FDA product code for VISTA ANTIGEN BRUCELLA MELITENSIS?

The FDA product code for VISTA ANTIGEN BRUCELLA MELITENSIS is GSO.

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Other records listing Lee Laboratories, 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.

K972389VISTA ANTIGEN SALMONELLA H DK972387VISTA ANTIGEN SALMONELLA O GROUP AK972394VISTA ANTIGEN BRUCELLA ABORTUSK972388VISTA ANTIGEN SALMONELLA O GROUP CK972386VISTA ANTIGEN SALMONELLA O GROUP BK972395VISTA ANTIGEN SALMONELLA O GROUP D

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Related Devices (Code: GSO)

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.

K972394VISTA ANTIGEN BRUCELLA ABORTUSLee Laboratories, Inc.K952139SAS BRUCELLA SUIS ANTIGENSa Scientific, Inc.K952140SAS BRUCELLA MELTIENSIS ANTIGENSa Scientific, Inc.K952147SAS BRUCELLA ABORTUS ANTIGENSa Scientific, Inc.K952131SAS FEBRILE ANTIGEN SETSa Scientific, Inc.K952135SAS SALMONELLA H D ANTIGENSa Scientific, 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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