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FDA 510(k)

ALKALINE PHOSPHATASE IN SERUM

K-Number: K781609 · 1978-10-24

ApplicantFisher Scientific Co., LLC
Decision Date1978-10-24
Product CodeCJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALKALINE PHOSPHATASE IN SERUM is the device name listed in this FDA 510(k) record. The listed applicant is Fisher Scientific Co., LLC. It received FDA 510(k) clearance on 1978-10-24 under 510(k) number K781609. 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 IN SERUM?

ALKALINE PHOSPHATASE IN SERUM is a medical device that received FDA 510(k) clearance on 1978-10-24. The listed applicant is Fisher Scientific Co., LLC. The 510(k) number is K781609.

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

ALKALINE PHOSPHATASE IN SERUM received FDA 510(k) clearance on 1978-10-24, under 510(k) number K781609.

Who is the listed applicant for ALKALINE PHOSPHATASE IN SERUM?

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

What is the FDA product code for ALKALINE PHOSPHATASE IN SERUM?

The FDA product code for ALKALINE PHOSPHATASE IN SERUM is CJE.

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Other records listing Fisher Scientific Co., LLC as applicant

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K930415MICROHEMATOCRIT ROTORK915825MARATHON 6K GENERAL-PURPOSE CENTRIFUGEK915441MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGEK890534MODIFIED URIQUAL(TM) URINALYSIS CONTROL LEVEL 1K881275URIQUAL(TM) URINALYSIS CONTROLS (HUMAN) I & IIK874054FISHER DIAGNOSTICS HEMATALL III LAS REAGENT

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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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