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FDA 510(k)

HUMAN C1 INACTIVATOR KIT FOR USE ON SPAPLUS

K-Number: K122304 · 2013-04-15

ApplicantThe Binding Site Group , Ltd.
Decision Date2013-04-15
Product CodeDBA
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

HUMAN C1 INACTIVATOR KIT FOR USE ON SPAPLUS is the device name listed in this FDA 510(k) record. The listed applicant is The Binding Site Group , Ltd.. It received FDA 510(k) clearance on 2013-04-15 under 510(k) number K122304. 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 HUMAN C1 INACTIVATOR KIT FOR USE ON SPAPLUS?

HUMAN C1 INACTIVATOR KIT FOR USE ON SPAPLUS is a medical device that received FDA 510(k) clearance on 2013-04-15. The listed applicant is The Binding Site Group , Ltd.. The 510(k) number is K122304.

When did HUMAN C1 INACTIVATOR KIT FOR USE ON SPAPLUS receive FDA 510(k) clearance?

HUMAN C1 INACTIVATOR KIT FOR USE ON SPAPLUS received FDA 510(k) clearance on 2013-04-15, under 510(k) number K122304.

Who is the listed applicant for HUMAN C1 INACTIVATOR KIT FOR USE ON SPAPLUS?

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

What is the FDA product code for HUMAN C1 INACTIVATOR KIT FOR USE ON SPAPLUS?

The FDA product code for HUMAN C1 INACTIVATOR KIT FOR USE ON SPAPLUS 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.

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.K951967HUMAN C1 INACTIVATOR OR C-1 ESTERASE INHIBITOR RADIAL IMMUNODIFFUSION KITKent Laboratories, 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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