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FDA 510(k)

HUMAN CERULOPLASMIN

K-Number: K791339 · 1979-08-16

ApplicantBeckman Instruments, Inc.
Decision Date1979-08-16
Product CodeDDB
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

HUMAN CERULOPLASMIN is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Instruments, Inc.. It received FDA 510(k) clearance on 1979-08-16 under 510(k) number K791339. 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 HUMAN CERULOPLASMIN?

HUMAN CERULOPLASMIN is a medical device that received FDA 510(k) clearance on 1979-08-16. The listed applicant is Beckman Instruments, Inc.. The 510(k) number is K791339.

When did HUMAN CERULOPLASMIN receive FDA 510(k) clearance?

HUMAN CERULOPLASMIN received FDA 510(k) clearance on 1979-08-16, under 510(k) number K791339.

Who is the listed applicant for HUMAN CERULOPLASMIN?

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

What is the FDA product code for HUMAN CERULOPLASMIN?

The FDA product code for HUMAN CERULOPLASMIN is DDB.

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Other records listing Beckman Instruments, 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.

K973448ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 34460, 34465, 34469K982250ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZERK981403IMMAGE IMMUNOCHEMISTRY SYSTEM VALPROIC ACID (VPA) REAGENTK981354ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211K980173ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER; 33500, 33505K974816ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229

View all 281 devices →

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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