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FDA 510(k)

NOVA IV FLUIDS PACK & EXTERNAL STANDARDS

K-Number: K821623 · 1982-06-14

ApplicantShaban Mfg. Co.
Decision Date1982-06-14
Product CodeJIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

NOVA IV FLUIDS PACK & EXTERNAL STANDARDS is the device name listed in this FDA 510(k) record. The listed applicant is Shaban Mfg. Co.. It received FDA 510(k) clearance on 1982-06-14 under 510(k) number K821623. 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 NOVA IV FLUIDS PACK & EXTERNAL STANDARDS?

NOVA IV FLUIDS PACK & EXTERNAL STANDARDS is a medical device that received FDA 510(k) clearance on 1982-06-14. The listed applicant is Shaban Mfg. Co.. The 510(k) number is K821623.

When did NOVA IV FLUIDS PACK & EXTERNAL STANDARDS receive FDA 510(k) clearance?

NOVA IV FLUIDS PACK & EXTERNAL STANDARDS received FDA 510(k) clearance on 1982-06-14, under 510(k) number K821623.

Who is the listed applicant for NOVA IV FLUIDS PACK & EXTERNAL STANDARDS?

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

What is the FDA product code for NOVA IV FLUIDS PACK & EXTERNAL STANDARDS?

The FDA product code for NOVA IV FLUIDS PACK & EXTERNAL STANDARDS is JIX.

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Other records listing Shaban Mfg. Co. 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.

K853621REPLACEMENT PUMP TUBINGK850157CANNULAS FOR HEMA-TEK I & KK SLIDE STAINERSK850333PUMP TUBE SETS FOR HEMA-TEK I & II SLIDE STAINERSK844781MEMBRANE KITS-KC1, CO2 & 02 FOR INSTRUMENT-LABK844235CHLORIDE STANDARDK842656REPLACEMENT PARTS NOVA ELECTROLYTE ANAL

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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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