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FDA 510(k)

KLINAR REAGENT PAK, #36010

K-Number: K801892 · 1980-10-23

ApplicantHi Chem, Inc.
Decision Date1980-10-23
Product CodeJGT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

KLINAR REAGENT PAK, #36010 is the device name listed in this FDA 510(k) record. The listed applicant is Hi Chem, Inc.. It received FDA 510(k) clearance on 1980-10-23 under 510(k) number K801892. The device is classified under product code JGT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KLINAR REAGENT PAK, #36010?

KLINAR REAGENT PAK, #36010 is a medical device that received FDA 510(k) clearance on 1980-10-23. The listed applicant is Hi Chem, Inc.. The 510(k) number is K801892.

When did KLINAR REAGENT PAK, #36010 receive FDA 510(k) clearance?

KLINAR REAGENT PAK, #36010 received FDA 510(k) clearance on 1980-10-23, under 510(k) number K801892.

Who is the listed applicant for KLINAR REAGENT PAK, #36010?

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

What is the FDA product code for KLINAR REAGENT PAK, #36010?

The FDA product code for KLINAR REAGENT PAK, #36010 is JGT.

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Other records listing Hi Chem, Inc. as applicant

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Related Devices (Code: JGT)

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K896829TECHNICON RA SYSTEMS SODIUM (COLORIMETRIC METHOD)Technicon Instruments Corp.K891574LITHIUM CONCENTRATE #SR1031, NA/K STANDARDS SR1030Em Diagnostic Systems, Inc.K841610COMPONENTS FOR POTASSIUM, SODIUM CHLOShaban Mfg. Co.K840216SODIUM/POTASSIUM REAGENT SYSSclavo, Inc.K834248PARALLEL FLAME PHOTOMETER & SODIUMAmerican Monitor Corp.K811886CESIUM DILUENT 7.5MGilford 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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