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FDA 510(k)

ALKALINE PHOSPHATASE

K-Number: K852784 · 1985-07-22

ApplicantAdvanced Biomedical Methods, Inc.
Decision Date1985-07-22
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 Advanced Biomedical Methods, Inc.. It received FDA 510(k) clearance on 1985-07-22 under 510(k) number K852784. 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 1985-07-22. The listed applicant is Advanced Biomedical Methods, Inc.. The 510(k) number is K852784.

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

ALKALINE PHOSPHATASE received FDA 510(k) clearance on 1985-07-22, under 510(k) number K852784.

Who is the listed applicant for ALKALINE PHOSPHATASE?

The FDA 510(k) record lists Advanced Biomedical Methods, 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 Advanced Biomedical Methods, 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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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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