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FDA 510(k)

ABBOTT QUICKSTART ALKA PHOSPHATASE (ALP) ITEM#5A38

K-Number: K913921 · 1991-11-22

ApplicantEm Diagnostic Systems, Inc.
Decision Date1991-11-22
Product CodeCJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ABBOTT QUICKSTART ALKA PHOSPHATASE (ALP) ITEM#5A38 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 1991-11-22 under 510(k) number K913921. 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 ABBOTT QUICKSTART ALKA PHOSPHATASE (ALP) ITEM#5A38?

ABBOTT QUICKSTART ALKA PHOSPHATASE (ALP) ITEM#5A38 is a medical device that received FDA 510(k) clearance on 1991-11-22. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K913921.

When did ABBOTT QUICKSTART ALKA PHOSPHATASE (ALP) ITEM#5A38 receive FDA 510(k) clearance?

ABBOTT QUICKSTART ALKA PHOSPHATASE (ALP) ITEM#5A38 received FDA 510(k) clearance on 1991-11-22, under 510(k) number K913921.

Who is the listed applicant for ABBOTT QUICKSTART ALKA PHOSPHATASE (ALP) ITEM#5A38?

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 ABBOTT QUICKSTART ALKA PHOSPHATASE (ALP) ITEM#5A38?

The FDA product code for ABBOTT QUICKSTART ALKA PHOSPHATASE (ALP) ITEM#5A38 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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