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FDA 510(k)

ESKLAB REAGENT TABLETS

K-Number: K790918 · 1979-06-22

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

Device Summary

ESKLAB REAGENT TABLETS 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 K790918. 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 ESKLAB REAGENT TABLETS?

ESKLAB REAGENT TABLETS 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 K790918.

When did ESKLAB REAGENT TABLETS receive FDA 510(k) clearance?

ESKLAB REAGENT TABLETS received FDA 510(k) clearance on 1979-06-22, under 510(k) number K790918.

Who is the listed applicant for ESKLAB REAGENT TABLETS?

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 ESKLAB REAGENT TABLETS?

The FDA product code for ESKLAB REAGENT TABLETS is 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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