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FDA 510(k)

COMPLEMENT C1 INACTIVATOR KIT

K-Number: K915431 · 1992-01-17

ApplicantThe Binding Site, Ltd.
Decision Date1992-01-17
Product CodeDBA
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

COMPLEMENT C1 INACTIVATOR KIT is the device name listed in this FDA 510(k) record. The listed applicant is The Binding Site, Ltd.. It received FDA 510(k) clearance on 1992-01-17 under 510(k) number K915431. 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 COMPLEMENT C1 INACTIVATOR KIT?

COMPLEMENT C1 INACTIVATOR KIT is a medical device that received FDA 510(k) clearance on 1992-01-17. The listed applicant is The Binding Site, Ltd.. The 510(k) number is K915431.

When did COMPLEMENT C1 INACTIVATOR KIT receive FDA 510(k) clearance?

COMPLEMENT C1 INACTIVATOR KIT received FDA 510(k) clearance on 1992-01-17, under 510(k) number K915431.

Who is the listed applicant for COMPLEMENT C1 INACTIVATOR KIT?

The FDA 510(k) record lists The Binding Site, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COMPLEMENT C1 INACTIVATOR KIT?

The FDA product code for COMPLEMENT C1 INACTIVATOR KIT is DBA.

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Other records listing The Binding Site, Ltd. 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.

K231290Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free KitK090920HUMAN IGG SUBCLASS LIQUID REAGENT KITS (FOR USE ON HITACHI 911/ 912/ 917 AND MODULAR P)K083289HUMAN BETA-2 MICROGLOBULIN KITK082129HUMAN IGM LIQUID REAGENT KIT FOR USE ON THE SPAPLUS ANALYZERK081827HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPAPLUSK081674BINDAZYME HUMAN ANTI-GLIADIN (MGP), IGG EIA KIT; BINDAZYME HUMAN ANTI-GLIADIN (MGP) IGA EIA KIT; (IGA OR IGG)

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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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