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FDA 510(k)

N ANTISERUM TO C1 INHIBITOR

K-Number: K960257 · 1996-08-01

ApplicantBehring Diagnostics, Inc.
Decision Date1996-08-01
Product CodeDBA
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

N ANTISERUM TO C1 INHIBITOR is the device name listed in this FDA 510(k) record. The listed applicant is Behring Diagnostics, Inc.. It received FDA 510(k) clearance on 1996-08-01 under 510(k) number K960257. 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 N ANTISERUM TO C1 INHIBITOR?

N ANTISERUM TO C1 INHIBITOR is a medical device that received FDA 510(k) clearance on 1996-08-01. The listed applicant is Behring Diagnostics, Inc.. The 510(k) number is K960257.

When did N ANTISERUM TO C1 INHIBITOR receive FDA 510(k) clearance?

N ANTISERUM TO C1 INHIBITOR received FDA 510(k) clearance on 1996-08-01, under 510(k) number K960257.

Who is the listed applicant for N ANTISERUM TO C1 INHIBITOR?

The FDA 510(k) record lists Behring Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for N ANTISERUM TO C1 INHIBITOR?

The FDA product code for N ANTISERUM TO C1 INHIBITOR is DBA.

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Other records listing Behring Diagnostics, Inc. 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.

K973832OPUS HLH CONTROLSK972929N ANTISERUM TO HUMAN ALBUMINK972840N ANTISERUM TO HUMAN TRANSFERRINK973202MODIFICATION OF OPUS FERRITIN TEST SYSTEMK972316OPUS D-DIMERK972116VON WILLEBRAND REAGENT

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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.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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