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FDA 510(k)

LAS-R HUMAN C1 ESTERASE INHIBITOR TEST

K-Number: K780335 · 1978-03-22

ApplicantHyland Therapeutic Div., Travenol Laboratories
Decision Date1978-03-22
Product CodeDBA
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

LAS-R HUMAN C1 ESTERASE INHIBITOR 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 1978-03-22 under 510(k) number K780335. The device is classified under product code DBA. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LAS-R HUMAN C1 ESTERASE INHIBITOR TEST?

LAS-R HUMAN C1 ESTERASE INHIBITOR TEST is a medical device that received FDA 510(k) clearance on 1978-03-22. The listed applicant is Hyland Therapeutic Div., Travenol Laboratories. The 510(k) number is K780335.

When did LAS-R HUMAN C1 ESTERASE INHIBITOR TEST receive FDA 510(k) clearance?

LAS-R HUMAN C1 ESTERASE INHIBITOR TEST received FDA 510(k) clearance on 1978-03-22, under 510(k) number K780335.

Who is the listed applicant for LAS-R HUMAN C1 ESTERASE INHIBITOR 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 HUMAN C1 ESTERASE INHIBITOR TEST?

The FDA product code for LAS-R HUMAN C1 ESTERASE INHIBITOR TEST is DBA.

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Related Devices (Code: DBA)

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.

K122304HUMAN C1 INACTIVATOR KIT FOR USE ON SPAPLUSThe Binding Site Group , Ltd.K072965DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CONDade Behring, Inc.K011780K-ASSAY C1-INAKamiya Biomedical Co.K003747C1-INHIBITOR MICROTITER ASSAY DEVICEBaxter Healthcare CorpK965024N-ASSAY TIA C1-INACTIVATOR TEST KITCrestat Diagnostics, Inc.K960257N ANTISERUM TO C1 INHIBITORBehring Diagnostics, 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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