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FDA 510(k)

HEMOPEXIN NEPHELOMETRIC ASSAYS

K-Number: K780250 · 1978-02-28

ApplicantKallestad Laboratories, Inc.
Decision Date1978-02-28
Product CodeCZX
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

HEMOPEXIN NEPHELOMETRIC ASSAYS is the device name listed in this FDA 510(k) record. The listed applicant is Kallestad Laboratories, Inc.. It received FDA 510(k) clearance on 1978-02-28 under 510(k) number K780250. The device is classified under product code CZX. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMOPEXIN NEPHELOMETRIC ASSAYS?

HEMOPEXIN NEPHELOMETRIC ASSAYS is a medical device that received FDA 510(k) clearance on 1978-02-28. The listed applicant is Kallestad Laboratories, Inc.. The 510(k) number is K780250.

When did HEMOPEXIN NEPHELOMETRIC ASSAYS receive FDA 510(k) clearance?

HEMOPEXIN NEPHELOMETRIC ASSAYS received FDA 510(k) clearance on 1978-02-28, under 510(k) number K780250.

Who is the listed applicant for HEMOPEXIN NEPHELOMETRIC ASSAYS?

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

What is the FDA product code for HEMOPEXIN NEPHELOMETRIC ASSAYS?

The FDA product code for HEMOPEXIN NEPHELOMETRIC ASSAYS is CZX.

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Other records listing Kallestad 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.

K863681PATHFINDER(TM) DIRECT ANTIGEN DETECTION SYSTEMK862917PATHFINDER ROTAVIRUS CHEMILUMINESCENTK863682PATHFINDER(TM) SPECIMEN COLLECTION KITK862743PATHFINDER(TM) RESPIRATORY SYNCYTIAL VIRUSK862313KALLESTAD SM/RNP TEST REAGENTK862710KALLESTAD SSA/SSB ENA TEST REAGENTS

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Related Devices (Code: CZX)

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.

K801432HEMOPEXIN NEPHELOMETRIC ASSAYJ.T. Baker Chemical Co.K790713ANTISERUM TO HUMAN HEMOPEXINKent 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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