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FDA 510(k)

SGOT REAGENT SET

K-Number: K841065 · 1984-05-01

ApplicantMedical Specialties, Inc.
Decision Date1984-05-01
Product CodeCIQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SGOT REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Medical Specialties, Inc.. It received FDA 510(k) clearance on 1984-05-01 under 510(k) number K841065. The device is classified under product code CIQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SGOT REAGENT SET?

SGOT REAGENT SET is a medical device that received FDA 510(k) clearance on 1984-05-01. The listed applicant is Medical Specialties, Inc.. The 510(k) number is K841065.

When did SGOT REAGENT SET receive FDA 510(k) clearance?

SGOT REAGENT SET received FDA 510(k) clearance on 1984-05-01, under 510(k) number K841065.

Who is the listed applicant for SGOT REAGENT SET?

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

What is the FDA product code for SGOT REAGENT SET?

The FDA product code for SGOT REAGENT SET is CIQ.

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Other records listing Medical Specialties, 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.

K946201STAND, INFUSIONK931947CHECKPOINTK926095REFRACTROL-SPK924926MSI-HCTK896566MODIFIED FOX EXTRA GRAM NEGATIVE AND POSITIVEK883851MSI-CAL 8

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Related Devices (Code: CIQ)

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.

K881173ASPARTATE AMINOTRANSFERASE (COLORIMETRIC METHOD)Tech-Co, Inc.K860216SGOT (AST) REAGENT SETSterling Diagnostics, Inc.K855189GLUTAMIC OXALOACETIC TRANSAMINASE REAGENT SETTechnostics Intl.K844322SGOT REAGENT SETLivonia Diagnostics, Inc.K821209SGOT REAGENT SETOmega Medical ElectronicsK820466SGOT REAGENT SETAnco Medical Reagents & Assoc.

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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