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FDA 510(k)

TUBING KIT 446

K-Number: K832584 · 1983-09-12

ApplicantShaban Mfg. Co.
Decision Date1983-09-12
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TUBING KIT 446 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 1983-09-12 under 510(k) number K832584. The device is classified under product code JJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TUBING KIT 446?

TUBING KIT 446 is a medical device that received FDA 510(k) clearance on 1983-09-12. The listed applicant is Shaban Mfg. Co.. The 510(k) number is K832584.

When did TUBING KIT 446 receive FDA 510(k) clearance?

TUBING KIT 446 received FDA 510(k) clearance on 1983-09-12, under 510(k) number K832584.

Who is the listed applicant for TUBING KIT 446?

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 TUBING KIT 446?

The FDA product code for TUBING KIT 446 is JJE.

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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: JJE)

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.

K183375Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride ElectrodeHoriba, Ltd.K130276DIMENSION EXL WITH LM SYSTEMSiemens Healthcare Diagnostics, Inc.K113253ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN REAGENT,ACE BUN/UREANITROGEN REAGENTAlfa Wassermann Diagnostic Technologies, Inc.K112999DIMENSION CLINICAL CHEMISTRY SYSTEMSiemens Healthcare DiagnosticsK110035INDIKOThermofisher Scientific OYK073370TC MATRIX CLINICAL CHEMISTRY ANALYZERTeco Diagnostics

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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