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FDA 510(k)

LAS-R CERULOPLASMIN TEST

K-Number: K771795 · 1977-11-14

ApplicantHyland Therapeutic Div., Travenol Laboratories
Decision Date1977-11-14
Product CodeDDB
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

LAS-R CERULOPLASMIN TEST is the device name listed in this FDA 510(k) record. The listed applicant is Hyland Therapeutic Div., Travenol Laboratories. It received FDA 510(k) clearance on 1977-11-14 under 510(k) number K771795. 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 LAS-R CERULOPLASMIN TEST?

LAS-R CERULOPLASMIN TEST is a medical device that received FDA 510(k) clearance on 1977-11-14. The listed applicant is Hyland Therapeutic Div., Travenol Laboratories. The 510(k) number is K771795.

When did LAS-R CERULOPLASMIN TEST receive FDA 510(k) clearance?

LAS-R CERULOPLASMIN TEST received FDA 510(k) clearance on 1977-11-14, under 510(k) number K771795.

Who is the listed applicant for LAS-R CERULOPLASMIN TEST?

The FDA 510(k) record lists Hyland Therapeutic Div., Travenol Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LAS-R CERULOPLASMIN TEST?

The FDA product code for LAS-R CERULOPLASMIN TEST is DDB.

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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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