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FDA 510(k)

SPIN CHEM CK-NAC REAGENT

K-Number: K790917 · 1979-06-22

ApplicantSmithkline Diagnostics, Inc.
Decision Date1979-06-22
Product CodeJHS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SPIN CHEM CK-NAC REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Smithkline Diagnostics, Inc.. It received FDA 510(k) clearance on 1979-06-22 under 510(k) number K790917. The device is classified under product code JHS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPIN CHEM CK-NAC REAGENT?

SPIN CHEM CK-NAC REAGENT is a medical device that received FDA 510(k) clearance on 1979-06-22. The listed applicant is Smithkline Diagnostics, Inc.. The 510(k) number is K790917.

When did SPIN CHEM CK-NAC REAGENT receive FDA 510(k) clearance?

SPIN CHEM CK-NAC REAGENT received FDA 510(k) clearance on 1979-06-22, under 510(k) number K790917.

Who is the listed applicant for SPIN CHEM CK-NAC REAGENT?

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

What is the FDA product code for SPIN CHEM CK-NAC REAGENT?

The FDA product code for SPIN CHEM CK-NAC REAGENT is JHS.

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Related Devices (Code: JHS)

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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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