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FDA 510(k)

EASY-TEST ALKALINE PHOSPHATASE (ALP) #19021

K-Number: K873635 · 1987-10-29

ApplicantEm Diagnostic Systems, Inc.
Decision Date1987-10-29
Product CodeCJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EASY-TEST ALKALINE PHOSPHATASE (ALP) #19021 is the device name listed in this FDA 510(k) record. The listed applicant is Em Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1987-10-29 under 510(k) number K873635. 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 EASY-TEST ALKALINE PHOSPHATASE (ALP) #19021?

EASY-TEST ALKALINE PHOSPHATASE (ALP) #19021 is a medical device that received FDA 510(k) clearance on 1987-10-29. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K873635.

When did EASY-TEST ALKALINE PHOSPHATASE (ALP) #19021 receive FDA 510(k) clearance?

EASY-TEST ALKALINE PHOSPHATASE (ALP) #19021 received FDA 510(k) clearance on 1987-10-29, under 510(k) number K873635.

Who is the listed applicant for EASY-TEST ALKALINE PHOSPHATASE (ALP) #19021?

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

What is the FDA product code for EASY-TEST ALKALINE PHOSPHATASE (ALP) #19021?

The FDA product code for EASY-TEST ALKALINE PHOSPHATASE (ALP) #19021 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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