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FDA 510(k)

ALP REAGENT SET, ALKALINE PHOSPHATASE

K-Number: K781718 · 1978-11-03

ApplicantMedical Analysis Systems, Inc.
Decision Date1978-11-03
Product CodeCJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALP REAGENT SET, ALKALINE PHOSPHATASE is the device name listed in this FDA 510(k) record. The listed applicant is Medical Analysis Systems, Inc.. It received FDA 510(k) clearance on 1978-11-03 under 510(k) number K781718. 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 ALP REAGENT SET, ALKALINE PHOSPHATASE?

ALP REAGENT SET, ALKALINE PHOSPHATASE is a medical device that received FDA 510(k) clearance on 1978-11-03. The listed applicant is Medical Analysis Systems, Inc.. The 510(k) number is K781718.

When did ALP REAGENT SET, ALKALINE PHOSPHATASE receive FDA 510(k) clearance?

ALP REAGENT SET, ALKALINE PHOSPHATASE received FDA 510(k) clearance on 1978-11-03, under 510(k) number K781718.

Who is the listed applicant for ALP REAGENT SET, ALKALINE PHOSPHATASE?

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

What is the FDA product code for ALP REAGENT SET, ALKALINE PHOSPHATASE?

The FDA product code for ALP REAGENT SET, ALKALINE PHOSPHATASE 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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