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FDA 510(k)

N PROTEIN STANDARD SY

K-Number: K952594 · 1995-07-17

ApplicantBehring Diagnostics, Inc.
Decision Date1995-07-17
Product CodeCZW
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

N PROTEIN STANDARD SY 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 1995-07-17 under 510(k) number K952594. 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 N PROTEIN STANDARD SY?

N PROTEIN STANDARD SY is a medical device that received FDA 510(k) clearance on 1995-07-17. The listed applicant is Behring Diagnostics, Inc.. The 510(k) number is K952594.

When did N PROTEIN STANDARD SY receive FDA 510(k) clearance?

N PROTEIN STANDARD SY received FDA 510(k) clearance on 1995-07-17, under 510(k) number K952594.

Who is the listed applicant for N PROTEIN STANDARD SY?

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 PROTEIN STANDARD SY?

The FDA product code for N PROTEIN STANDARD SY is CZW.

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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.

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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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