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FDA 510(k)

SODIUM/POTASSIUM REAGENT SYS

K-Number: K840216 · 1984-03-19

ApplicantSclavo, Inc.
Decision Date1984-03-19
Product CodeJGT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SODIUM/POTASSIUM REAGENT SYS is the device name listed in this FDA 510(k) record. The listed applicant is Sclavo, Inc.. It received FDA 510(k) clearance on 1984-03-19 under 510(k) number K840216. 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 SODIUM/POTASSIUM REAGENT SYS?

SODIUM/POTASSIUM REAGENT SYS is a medical device that received FDA 510(k) clearance on 1984-03-19. The listed applicant is Sclavo, Inc.. The 510(k) number is K840216.

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

SODIUM/POTASSIUM REAGENT SYS received FDA 510(k) clearance on 1984-03-19, under 510(k) number K840216.

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

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

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

The FDA product code for SODIUM/POTASSIUM REAGENT SYS is JGT.

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Other records listing Sclavo, 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.

K914789ELISA CMV IGMK914852ELISA TOXO IGMK914420ELISA RUBELLA IGMK895943NORMAL AND ABNORMAL CONTROL SERAK895822TOTAL BILIRUBIN L.F.K895847CREATININE 340 (ENZYMATIC)

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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.K891574LITHIUM CONCENTRATE #SR1031, NA/K STANDARDS SR1030Em Diagnostic Systems, Inc.K841610COMPONENTS FOR POTASSIUM, SODIUM CHLOShaban Mfg. Co.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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