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FDA 510(k)

ALKALINE PHOSPHATASE

K-Number: K812452 · 1981-09-09

ApplicantPointe Scientific, Inc.,
Decision Date1981-09-09
Product CodeCJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALKALINE PHOSPHATASE is the device name listed in this FDA 510(k) record. The listed applicant is Pointe Scientific, Inc.,. It received FDA 510(k) clearance on 1981-09-09 under 510(k) number K812452. 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 ALKALINE PHOSPHATASE?

ALKALINE PHOSPHATASE is a medical device that received FDA 510(k) clearance on 1981-09-09. The listed applicant is Pointe Scientific, Inc.,. The 510(k) number is K812452.

When did ALKALINE PHOSPHATASE receive FDA 510(k) clearance?

ALKALINE PHOSPHATASE received FDA 510(k) clearance on 1981-09-09, under 510(k) number K812452.

Who is the listed applicant for ALKALINE PHOSPHATASE?

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

What is the FDA product code for ALKALINE PHOSPHATASE?

The FDA product code for ALKALINE PHOSPHATASE is CJE.

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Other records listing Pointe Scientific, Inc., as applicant

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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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