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FDA 510(k)

SYNERMEDIR CAL I AND SYNERMED IR CAL II

K-Number: K940571 · 1994-04-21

ApplicantSynermed, Inc.
Decision Date1994-04-21
Product CodeJIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SYNERMEDIR CAL I AND SYNERMED IR CAL II is the device name listed in this FDA 510(k) record. The listed applicant is Synermed, Inc.. It received FDA 510(k) clearance on 1994-04-21 under 510(k) number K940571. 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 SYNERMEDIR CAL I AND SYNERMED IR CAL II?

SYNERMEDIR CAL I AND SYNERMED IR CAL II is a medical device that received FDA 510(k) clearance on 1994-04-21. The listed applicant is Synermed, Inc.. The 510(k) number is K940571.

When did SYNERMEDIR CAL I AND SYNERMED IR CAL II receive FDA 510(k) clearance?

SYNERMEDIR CAL I AND SYNERMED IR CAL II received FDA 510(k) clearance on 1994-04-21, under 510(k) number K940571.

Who is the listed applicant for SYNERMEDIR CAL I AND SYNERMED IR CAL II?

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

What is the FDA product code for SYNERMEDIR CAL I AND SYNERMED IR CAL II?

The FDA product code for SYNERMEDIR CAL I AND SYNERMED IR CAL II is JIX.

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Other records listing Synermed, 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.

K973109SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KITK972716SYNERMED TOTAL BILIRUBIN REAGENT KITK971491SYNERMED IR 200 CHEMISTRY ANALYZERK962479SYNERMED ISE REAGENTSK963939SYNERMED DIRECT BILIRUBIN REAGENT KITK960793SYNERMED ENZYMATIC CO2 REAGENT KIT

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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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