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FDA 510(k)

N PROTEIN STRANDARD SL

K-Number: K964062 · 1996-11-21

ApplicantBehring Diagnostics, Inc.
Decision Date1996-11-21
Product CodeJIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

N PROTEIN STRANDARD SL 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 1996-11-21 under 510(k) number K964062. The device is classified under product code JIX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the N PROTEIN STRANDARD SL?

N PROTEIN STRANDARD SL is a medical device that received FDA 510(k) clearance on 1996-11-21. The listed applicant is Behring Diagnostics, Inc.. The 510(k) number is K964062.

When did N PROTEIN STRANDARD SL receive FDA 510(k) clearance?

N PROTEIN STRANDARD SL received FDA 510(k) clearance on 1996-11-21, under 510(k) number K964062.

Who is the listed applicant for N PROTEIN STRANDARD SL?

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 STRANDARD SL?

The FDA product code for N PROTEIN STRANDARD SL is JIX.

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Other records listing Behring Diagnostics, Inc. as applicant

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Related Devices (Code: JIX)

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K161140VITROS Chemistry Products Calibrator Kit 3Ortho-Clinical Diagnostics, Inc.K133330C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEINRoche DiagnosticsK130765ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL IIElitechgroupK123321DIMENSION CHEMISTRY III CALIBRATORYSiemens Healthcare DiagnosticsK123372ABBOTT LIPID MULTI CONSTITUENT CALIBRATORAbbott LaboratoriesK122398RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORSSiemens Healthcare Diagnostics, 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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