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FDA 510(k)

ALKALINE PHOSPHATASE

K-Number: K864905 · 1987-01-13

ApplicantTech-Co, Inc.
Decision Date1987-01-13
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 Tech-Co, Inc.. It received FDA 510(k) clearance on 1987-01-13 under 510(k) number K864905. 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 1987-01-13. The listed applicant is Tech-Co, Inc.. The 510(k) number is K864905.

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

ALKALINE PHOSPHATASE received FDA 510(k) clearance on 1987-01-13, under 510(k) number K864905.

Who is the listed applicant for ALKALINE PHOSPHATASE?

The FDA 510(k) record lists Tech-Co, 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 Tech-Co, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: CJE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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