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FDA 510(k)

SODIUM/POTASSIUM REAGENT KIT

K-Number: K873126 · 1987-10-23

ApplicantA-Kem, Inc.
Decision Date1987-10-23
Product CodeJGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SODIUM/POTASSIUM REAGENT KIT is the device name listed in this FDA 510(k) record. The listed applicant is A-Kem, Inc.. It received FDA 510(k) clearance on 1987-10-23 under 510(k) number K873126. The device is classified under product code JGS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SODIUM/POTASSIUM REAGENT KIT?

SODIUM/POTASSIUM REAGENT KIT is a medical device that received FDA 510(k) clearance on 1987-10-23. The listed applicant is A-Kem, Inc.. The 510(k) number is K873126.

When did SODIUM/POTASSIUM REAGENT KIT receive FDA 510(k) clearance?

SODIUM/POTASSIUM REAGENT KIT received FDA 510(k) clearance on 1987-10-23, under 510(k) number K873126.

Who is the listed applicant for SODIUM/POTASSIUM REAGENT KIT?

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

What is the FDA product code for SODIUM/POTASSIUM REAGENT KIT?

The FDA product code for SODIUM/POTASSIUM REAGENT KIT is JGS.

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Other records listing A-Kem, Inc. 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.

K884224TOTAL BILIRUBIN REAGENT KIT FOR ASTRA SYSTEMSK884227CALIBRATOR STANDARD KIT FOR ASTRA SYSTEMK884225TOTAL PROTEIN REAGENT KIT FOR ASTRA SYSTEMSK884226AMYLASE REAGENT KIT FOR ASTRA SYSTEMSK882587A-KEM ALBUMIN REAGENT KIT FOR ASTRA SYSTEMK882586A-KEM CALCIUM REAGENT KIT FOR ASTRA SYSTEM

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Related Devices (Code: JGS)

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.

K252475ABL90 FLEX PLUS SystemRadiometer Medicals ApsK230275i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K222438A-LYTE® Integrated Multisensor (IMT Na K Cl)Siemens Healthcare Diagnostics, Inc.K220977ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry AnalyzerBeckman Coulter Laboratory Systems (Suzhou) Co., Ltd.K213486GLP systems TrackAbbott LaboratoriesK200403Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation

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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