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FDA 510(k)

ALKALINE PHOSPHATASE TEST

K-Number: K862498 · 1986-09-26

ApplicantKing Diagnostics, Inc.
Decision Date1986-09-26
Product CodeCJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALKALINE PHOSPHATASE TEST is the device name listed in this FDA 510(k) record. The listed applicant is King Diagnostics, Inc.. It received FDA 510(k) clearance on 1986-09-26 under 510(k) number K862498. 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 TEST?

ALKALINE PHOSPHATASE TEST is a medical device that received FDA 510(k) clearance on 1986-09-26. The listed applicant is King Diagnostics, Inc.. The 510(k) number is K862498.

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

ALKALINE PHOSPHATASE TEST received FDA 510(k) clearance on 1986-09-26, under 510(k) number K862498.

Who is the listed applicant for ALKALINE PHOSPHATASE TEST?

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

What is the FDA product code for ALKALINE PHOSPHATASE TEST?

The FDA product code for ALKALINE PHOSPHATASE TEST is CJE.

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Other records listing King Diagnostics, Inc. as applicant

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Related Devices (Code: 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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