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FDA 510(k)

SODIUM & POTASSIUM STANDARD SOL 80

K-Number: K841420 · 1984-05-11

ApplicantReagent Laboratory, Inc.
Decision Date1984-05-11
Product CodeJIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SODIUM & POTASSIUM STANDARD SOL 80 is the device name listed in this FDA 510(k) record. The listed applicant is Reagent Laboratory, Inc.. It received FDA 510(k) clearance on 1984-05-11 under 510(k) number K841420. 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 SODIUM & POTASSIUM STANDARD SOL 80?

SODIUM & POTASSIUM STANDARD SOL 80 is a medical device that received FDA 510(k) clearance on 1984-05-11. The listed applicant is Reagent Laboratory, Inc.. The 510(k) number is K841420.

When did SODIUM & POTASSIUM STANDARD SOL 80 receive FDA 510(k) clearance?

SODIUM & POTASSIUM STANDARD SOL 80 received FDA 510(k) clearance on 1984-05-11, under 510(k) number K841420.

Who is the listed applicant for SODIUM & POTASSIUM STANDARD SOL 80?

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

What is the FDA product code for SODIUM & POTASSIUM STANDARD SOL 80?

The FDA product code for SODIUM & POTASSIUM STANDARD SOL 80 is JIX.

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Other records listing Reagent Laboratory, 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.

K863502SOLUTION B- NA 50MEQ/L, K 40 MEQ/LK863503HEMOLYSEK863550POTASSIUM HYDROXIDE 10% W/VK860143URINE DILUENT-FOR USE WITH ION SELECTIVE ELECTRODEK842982FORMALIN BUFFEREDK842785STAIN, METHYLENE BLUE-EOSIN

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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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