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FDA 510(k)

ALKALINE PHOSPHATASE REAGENT SYSTEM

K-Number: K952746 · 1995-11-27

ApplicantMedical Diagnostic Technologies, Inc.
Decision Date1995-11-27
Product CodeCJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALKALINE PHOSPHATASE REAGENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medical Diagnostic Technologies, Inc.. It received FDA 510(k) clearance on 1995-11-27 under 510(k) number K952746. The device is classified under product code CJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALKALINE PHOSPHATASE REAGENT SYSTEM?

ALKALINE PHOSPHATASE REAGENT SYSTEM is a medical device that received FDA 510(k) clearance on 1995-11-27. The listed applicant is Medical Diagnostic Technologies, Inc.. The 510(k) number is K952746.

When did ALKALINE PHOSPHATASE REAGENT SYSTEM receive FDA 510(k) clearance?

ALKALINE PHOSPHATASE REAGENT SYSTEM received FDA 510(k) clearance on 1995-11-27, under 510(k) number K952746.

Who is the listed applicant for ALKALINE PHOSPHATASE REAGENT SYSTEM?

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

What is the FDA product code for ALKALINE PHOSPHATASE REAGENT SYSTEM?

The FDA product code for ALKALINE PHOSPHATASE REAGENT SYSTEM is CJE.

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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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