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FDA 510(k)

DATA-ZYME ALKALINE PHOSPHATASE PROCED

K-Number: K831360 · 1983-06-08

ApplicantData Medical Associates, Inc.
Decision Date1983-06-08
Product CodeCJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DATA-ZYME ALKALINE PHOSPHATASE PROCED is the device name listed in this FDA 510(k) record. The listed applicant is Data Medical Associates, Inc.. It received FDA 510(k) clearance on 1983-06-08 under 510(k) number K831360. 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 DATA-ZYME ALKALINE PHOSPHATASE PROCED?

DATA-ZYME ALKALINE PHOSPHATASE PROCED is a medical device that received FDA 510(k) clearance on 1983-06-08. The listed applicant is Data Medical Associates, Inc.. The 510(k) number is K831360.

When did DATA-ZYME ALKALINE PHOSPHATASE PROCED receive FDA 510(k) clearance?

DATA-ZYME ALKALINE PHOSPHATASE PROCED received FDA 510(k) clearance on 1983-06-08, under 510(k) number K831360.

Who is the listed applicant for DATA-ZYME ALKALINE PHOSPHATASE PROCED?

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

What is the FDA product code for DATA-ZYME ALKALINE PHOSPHATASE PROCED?

The FDA product code for DATA-ZYME ALKALINE PHOSPHATASE PROCED 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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