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FDA 510(k)

PACIFIC HEMOSTASIS REFERENCE EMULSION

K-Number: K013397 · 2002-02-15

ApplicantFisher Diagnostics
Decision Date2002-02-15
Product CodeJIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PACIFIC HEMOSTASIS REFERENCE EMULSION is the device name listed in this FDA 510(k) record. The listed applicant is Fisher Diagnostics. It received FDA 510(k) clearance on 2002-02-15 under 510(k) number K013397. 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 PACIFIC HEMOSTASIS REFERENCE EMULSION?

PACIFIC HEMOSTASIS REFERENCE EMULSION is a medical device that received FDA 510(k) clearance on 2002-02-15. The listed applicant is Fisher Diagnostics. The 510(k) number is K013397.

When did PACIFIC HEMOSTASIS REFERENCE EMULSION receive FDA 510(k) clearance?

PACIFIC HEMOSTASIS REFERENCE EMULSION received FDA 510(k) clearance on 2002-02-15, under 510(k) number K013397.

Who is the listed applicant for PACIFIC HEMOSTASIS REFERENCE EMULSION?

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

What is the FDA product code for PACIFIC HEMOSTASIS REFERENCE EMULSION?

The FDA product code for PACIFIC HEMOSTASIS REFERENCE EMULSION is JIX.

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Other records listing Fisher Diagnostics as applicant

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K170652ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT ControlsK070640ARCHITECT STAT TROPONIN-1; MYOGLOBINK052407ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLSK052308ARCHITECT ANTI-TG IMMUNOASSAY REAGENTS, CALIBRATORS, CONTROLS AND SYSTEM ASSAY CD-ROMK042924ARCHITECT STAT MYO IMMUNOASSAYK041192ARCHITECT STAT TROPONIN-I IMMUNOASSAY

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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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