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FDA 510(k)

REPLACEMENT PARTS NOVA ELECTROLYTE ANAL

K-Number: K842656 · 1984-08-12

ApplicantShaban Mfg. Co.
Decision Date1984-08-12
Product CodeJFL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

REPLACEMENT PARTS NOVA ELECTROLYTE ANAL 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 1984-08-12 under 510(k) number K842656. The device is classified under product code JFL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REPLACEMENT PARTS NOVA ELECTROLYTE ANAL?

REPLACEMENT PARTS NOVA ELECTROLYTE ANAL is a medical device that received FDA 510(k) clearance on 1984-08-12. The listed applicant is Shaban Mfg. Co.. The 510(k) number is K842656.

When did REPLACEMENT PARTS NOVA ELECTROLYTE ANAL receive FDA 510(k) clearance?

REPLACEMENT PARTS NOVA ELECTROLYTE ANAL received FDA 510(k) clearance on 1984-08-12, under 510(k) number K842656.

Who is the listed applicant for REPLACEMENT PARTS NOVA ELECTROLYTE ANAL?

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 REPLACEMENT PARTS NOVA ELECTROLYTE ANAL?

The FDA product code for REPLACEMENT PARTS NOVA ELECTROLYTE ANAL is JFL.

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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 TUBINGK850333PUMP TUBE SETS FOR HEMA-TEK I & II SLIDE STAINERSK850157CANNULAS FOR HEMA-TEK I & KK SLIDE STAINERSK844781MEMBRANE KITS-KC1, CO2 & 02 FOR INSTRUMENT-LABK844235CHLORIDE STANDARDK841609COMPONENTS FOR PARTIAL PRESSURE ELEE

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Related Devices (Code: JFL)

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.

K191298i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K040975GENCHEM CO2 ACID REAGENTGenchem, Inc.K014034MODIFICATION TO SYNCHRON LX CLINICAL CHEMISTRY SYSTEMS (LX20 AND LX20 PRO)Beckman Coulter, Inc.K963541SIGMA DIAGNOSTICS CO2 ACID REAGENTSigma Diagnostics, Inc.K963538SIGMA DIAGNOSTICS CO2ALKALINE BUFFERSigma Diagnostics, Inc.K963540SIGMA DIAGNOSTICS ELECTROLYTE BUFFERSigma 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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