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FDA 510(k)

CERULOPLASMIN NEPHEL. ASSAY

K-Number: K772255 · 1978-01-05

ApplicantKallestad Laboratories, Inc.
Decision Date1978-01-05
Product CodeDDB
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

CERULOPLASMIN NEPHEL. ASSAY 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 1978-01-05 under 510(k) number K772255. The device is classified under product code DDB. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CERULOPLASMIN NEPHEL. ASSAY?

CERULOPLASMIN NEPHEL. ASSAY is a medical device that received FDA 510(k) clearance on 1978-01-05. The listed applicant is Kallestad Laboratories, Inc.. The 510(k) number is K772255.

When did CERULOPLASMIN NEPHEL. ASSAY receive FDA 510(k) clearance?

CERULOPLASMIN NEPHEL. ASSAY received FDA 510(k) clearance on 1978-01-05, under 510(k) number K772255.

Who is the listed applicant for CERULOPLASMIN NEPHEL. ASSAY?

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 CERULOPLASMIN NEPHEL. ASSAY?

The FDA product code for CERULOPLASMIN NEPHEL. ASSAY is DDB.

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Other records listing Kallestad Laboratories, Inc. as applicant

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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: DDB)

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.

K161508CeruloplasminBeckman Coulter Ireland, Inc.K122965HUMAN CAERULOPLASMIN KITThe Binding Site Group , Ltd.K053074N ANTISERA TO HUMAN CERULOPLASMINDade Behring, Inc.K964762IMMAGE IMMUNOCHEMISTRY SYSTEM CERULOPLASMIN (CER) REAGENTBeckman Instruments, Inc.K913668CAERULOPLASMIN IMMUNOLOGICAL NL TEST KITThe Binding Site, Ltd.K895377QM300 CERULOPLASMIN ANTIBODY PACKKallestad Diag, A Div. of Erbamont, 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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