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FDA 510(k)

MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATOR

K-Number: K984425 · 1999-01-20

ApplicantBoehringer Mannheim Corp.
Decision Date1999-01-20
Product CodeJIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Boehringer Mannheim Corp.. It received FDA 510(k) clearance on 1999-01-20 under 510(k) number K984425. 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 MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATOR?

MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATOR is a medical device that received FDA 510(k) clearance on 1999-01-20. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K984425.

When did MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATOR receive FDA 510(k) clearance?

MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATOR received FDA 510(k) clearance on 1999-01-20, under 510(k) number K984425.

Who is the listed applicant for MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATOR?

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

What is the FDA product code for MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATOR?

The FDA product code for MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATOR is JIX.

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Other records listing Boehringer Mannheim Corp. 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.

K984326ELECYS IGE ASSAYK983047ACCU-CHEK HQ SYSTEMK984419ELECSYS IGE CALCHECKK984372ELECSYS CALCHECK TROPONIN TK984105ELECSYS TROPONIN T STAT TESTK983503ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS REAGENT CATALOG NUMBER 1730347

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Related Devices (Code: JIX)

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.

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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