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FDA 510(k)

C3 MININEPH ANTISERUM

K-Number: K981783 · 1999-12-20

ApplicantThe Binding Site, Ltd.
Decision Date1999-12-20
Product CodeCZW
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

C3 MININEPH ANTISERUM 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 1999-12-20 under 510(k) number K981783. The device is classified under product code CZW. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the C3 MININEPH ANTISERUM?

C3 MININEPH ANTISERUM is a medical device that received FDA 510(k) clearance on 1999-12-20. The listed applicant is The Binding Site, Ltd.. The 510(k) number is K981783.

When did C3 MININEPH ANTISERUM receive FDA 510(k) clearance?

C3 MININEPH ANTISERUM received FDA 510(k) clearance on 1999-12-20, under 510(k) number K981783.

Who is the listed applicant for C3 MININEPH ANTISERUM?

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 C3 MININEPH ANTISERUM?

The FDA product code for C3 MININEPH ANTISERUM is CZW.

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Other records listing The Binding Site, Ltd. as applicant

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Related Devices (Code: CZW)

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.

K100179SPAPLUSThe Binding Site Group , Ltd.K063150COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROLThermo Electron OYK061852DIMENSION VISTA C3 AND C4 FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL LOW, MEDIUM, HIGHDade Behring, Inc.K050665N ANTISERA TO HUMAN COMPLEMENT FACTORS (C3C, C4)Dade Behring, Inc.K042494VITROS CHEMISTRY PRODUCTS C3 AND CR REAGENT, CALIBRATOR KIT 20, PROTEIN PERFORMANCE VERIFIERS I, II, AND IIIOrtho-Clinical DiagnosticsK032796IBL C3D-CIC EIA TESTIbl GmbH

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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