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FDA 510(k)

IMMUNO/FEBRILE ANTIGENS

K-Number: K883685 · 1988-09-28

ApplicantImmunostics Co., Inc.
Decision Date1988-09-28
Product CodeGNC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

IMMUNO/FEBRILE ANTIGENS is the device name listed in this FDA 510(k) record. The listed applicant is Immunostics Co., Inc.. It received FDA 510(k) clearance on 1988-09-28 under 510(k) number K883685. 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 IMMUNO/FEBRILE ANTIGENS?

IMMUNO/FEBRILE ANTIGENS is a medical device that received FDA 510(k) clearance on 1988-09-28. The listed applicant is Immunostics Co., Inc.. The 510(k) number is K883685.

When did IMMUNO/FEBRILE ANTIGENS receive FDA 510(k) clearance?

IMMUNO/FEBRILE ANTIGENS received FDA 510(k) clearance on 1988-09-28, under 510(k) number K883685.

Who is the listed applicant for IMMUNO/FEBRILE ANTIGENS?

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

What is the FDA product code for IMMUNO/FEBRILE ANTIGENS?

The FDA product code for IMMUNO/FEBRILE ANTIGENS is GNC.

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Other records listing Immunostics Co., 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.

K926569IMMUNO RA UNDILUTEDK902360HEMA-SCREENK894780IMMUNO/ASOK872910IMMUNO/SLEK863741IMMUNO-CEPT D (BETA-MONOCLONAL)K854619DETECTACULT

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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.

K972388VISTA ANTIGEN SALMONELLA O GROUP CLee Laboratories, Inc.K972395VISTA ANTIGEN SALMONELLA O GROUP DLee Laboratories, Inc.K972389VISTA ANTIGEN SALMONELLA H DLee Laboratories, Inc.K972387VISTA ANTIGEN SALMONELLA O GROUP ALee Laboratories, Inc.K972386VISTA ANTIGEN SALMONELLA O GROUP BLee Laboratories, Inc.K972391VISTA ANTIGEN SALMONELLA H BLee 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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