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FDA 510(k)

C1-INHIBITOR MICROTITER ASSAY DEVICE

K-Number: K003747 · 2001-03-19

ApplicantBaxter Healthcare Corp
Decision Date2001-03-19
Product CodeDBA
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

C1-INHIBITOR MICROTITER ASSAY DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 2001-03-19 under 510(k) number K003747. 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 C1-INHIBITOR MICROTITER ASSAY DEVICE?

C1-INHIBITOR MICROTITER ASSAY DEVICE is a medical device that received FDA 510(k) clearance on 2001-03-19. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K003747.

When did C1-INHIBITOR MICROTITER ASSAY DEVICE receive FDA 510(k) clearance?

C1-INHIBITOR MICROTITER ASSAY DEVICE received FDA 510(k) clearance on 2001-03-19, under 510(k) number K003747.

Who is the listed applicant for C1-INHIBITOR MICROTITER ASSAY DEVICE?

The FDA 510(k) record lists Baxter Healthcare Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for C1-INHIBITOR MICROTITER ASSAY DEVICE?

The FDA product code for C1-INHIBITOR MICROTITER ASSAY DEVICE 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.K965024N-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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