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FDA 510(k)

VISTA ANTIGEN SALMONELLA H D

K-Number: K972389 · 1997-08-25

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

Device Summary

VISTA ANTIGEN SALMONELLA H D 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 K972389. The device is classified under product code GNC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VISTA ANTIGEN SALMONELLA H D?

VISTA ANTIGEN SALMONELLA H D 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 K972389.

When did VISTA ANTIGEN SALMONELLA H D receive FDA 510(k) clearance?

VISTA ANTIGEN SALMONELLA H D received FDA 510(k) clearance on 1997-08-25, under 510(k) number K972389.

Who is the listed applicant for VISTA ANTIGEN SALMONELLA H D?

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 SALMONELLA H D?

The FDA product code for VISTA ANTIGEN SALMONELLA H D is GNC.

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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.

K972387VISTA ANTIGEN SALMONELLA O GROUP AK972394VISTA ANTIGEN BRUCELLA ABORTUSK972388VISTA ANTIGEN SALMONELLA O GROUP CK972386VISTA ANTIGEN SALMONELLA O GROUP BK972395VISTA ANTIGEN SALMONELLA O GROUP DK972391VISTA ANTIGEN SALMONELLA H B

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Related Devices (Code: GNC)

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.

K972386VISTA ANTIGEN SALMONELLA O GROUP BLee Laboratories, Inc.K972391VISTA ANTIGEN SALMONELLA H BLee Laboratories, Inc.K972387VISTA ANTIGEN SALMONELLA O GROUP ALee Laboratories, Inc.K972388VISTA ANTIGEN SALMONELLA O GROUP CLee Laboratories, Inc.K972395VISTA ANTIGEN SALMONELLA O GROUP DLee Laboratories, Inc.K972392VISTA ANTIGEN SALMONELLA H ALee Laboratories, 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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