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FDA 510(k)

EASY-TEST AMYLASE (AMYL), ITEM NUMBER 19019

K-Number: K874705 · 1987-12-22

ApplicantEm Diagnostic Systems, Inc.
Decision Date1987-12-22
Product CodeJEJ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

EASY-TEST AMYLASE (AMYL), ITEM NUMBER 19019 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 1987-12-22 under 510(k) number K874705. The device is classified under product code JEJ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EASY-TEST AMYLASE (AMYL), ITEM NUMBER 19019?

EASY-TEST AMYLASE (AMYL), ITEM NUMBER 19019 is a medical device that received FDA 510(k) clearance on 1987-12-22. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K874705.

When did EASY-TEST AMYLASE (AMYL), ITEM NUMBER 19019 receive FDA 510(k) clearance?

EASY-TEST AMYLASE (AMYL), ITEM NUMBER 19019 received FDA 510(k) clearance on 1987-12-22, under 510(k) number K874705.

Who is the listed applicant for EASY-TEST AMYLASE (AMYL), ITEM NUMBER 19019?

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 AMYLASE (AMYL), ITEM NUMBER 19019?

The FDA product code for EASY-TEST AMYLASE (AMYL), ITEM NUMBER 19019 is JEJ.

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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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