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FDA 510(k)

U.S. DIAGNOSTICS ALKALINE PHOSPHATASE TEST

K-Number: K863980 · 1986-12-04

ApplicantU. S. Diagnostics, Inc.
Decision Date1986-12-04
Product CodeCJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

U.S. DIAGNOSTICS ALKALINE PHOSPHATASE TEST is the device name listed in this FDA 510(k) record. The listed applicant is U. S. Diagnostics, Inc.. It received FDA 510(k) clearance on 1986-12-04 under 510(k) number K863980. 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 U.S. DIAGNOSTICS ALKALINE PHOSPHATASE TEST?

U.S. DIAGNOSTICS ALKALINE PHOSPHATASE TEST is a medical device that received FDA 510(k) clearance on 1986-12-04. The listed applicant is U. S. Diagnostics, Inc.. The 510(k) number is K863980.

When did U.S. DIAGNOSTICS ALKALINE PHOSPHATASE TEST receive FDA 510(k) clearance?

U.S. DIAGNOSTICS ALKALINE PHOSPHATASE TEST received FDA 510(k) clearance on 1986-12-04, under 510(k) number K863980.

Who is the listed applicant for U.S. DIAGNOSTICS ALKALINE PHOSPHATASE TEST?

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

What is the FDA product code for U.S. DIAGNOSTICS ALKALINE PHOSPHATASE TEST?

The FDA product code for U.S. DIAGNOSTICS ALKALINE PHOSPHATASE TEST 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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