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FDA 510(k)

LITHIUM CONCENTRATE #SR1031, NA/K STANDARDS SR1030

K-Number: K891574 · 1989-06-09

ApplicantEm Diagnostic Systems, Inc.
Decision Date1989-06-09
Product CodeJGT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LITHIUM CONCENTRATE #SR1031, NA/K STANDARDS SR1030 is the device name listed in this FDA 510(k) record. The listed applicant is Em Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1989-06-09 under 510(k) number K891574. 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 LITHIUM CONCENTRATE #SR1031, NA/K STANDARDS SR1030?

LITHIUM CONCENTRATE #SR1031, NA/K STANDARDS SR1030 is a medical device that received FDA 510(k) clearance on 1989-06-09. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K891574.

When did LITHIUM CONCENTRATE #SR1031, NA/K STANDARDS SR1030 receive FDA 510(k) clearance?

LITHIUM CONCENTRATE #SR1031, NA/K STANDARDS SR1030 received FDA 510(k) clearance on 1989-06-09, under 510(k) number K891574.

Who is the listed applicant for LITHIUM CONCENTRATE #SR1031, NA/K STANDARDS SR1030?

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

What is the FDA product code for LITHIUM CONCENTRATE #SR1031, NA/K STANDARDS SR1030?

The FDA product code for LITHIUM CONCENTRATE #SR1031, NA/K STANDARDS SR1030 is JGT.

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Other records listing Em Diagnostic Systems, Inc. as applicant

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Related Devices (Code: JGT)

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.

K896829TECHNICON RA SYSTEMS SODIUM (COLORIMETRIC METHOD)Technicon Instruments Corp.K841610COMPONENTS FOR POTASSIUM, SODIUM CHLOShaban Mfg. Co.K840216SODIUM/POTASSIUM REAGENT SYSSclavo, Inc.K834248PARALLEL FLAME PHOTOMETER & SODIUMAmerican Monitor Corp.K811886CESIUM DILUENT 7.5MGilford DiagnosticsK801892KLINAR REAGENT PAK, #36010Hi Chem, 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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