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FDA 510(k)

KINETIC ALKALINE PHOSPHATASE REAGENT KIT

K-Number: K861638 · 1986-05-29

ApplicantBio-Analytics Laboratories, Inc.
Decision Date1986-05-29
Product CodeCJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

KINETIC ALKALINE PHOSPHATASE REAGENT KIT is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Analytics Laboratories, Inc.. It received FDA 510(k) clearance on 1986-05-29 under 510(k) number K861638. 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 KINETIC ALKALINE PHOSPHATASE REAGENT KIT?

KINETIC ALKALINE PHOSPHATASE REAGENT KIT is a medical device that received FDA 510(k) clearance on 1986-05-29. The listed applicant is Bio-Analytics Laboratories, Inc.. The 510(k) number is K861638.

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

KINETIC ALKALINE PHOSPHATASE REAGENT KIT received FDA 510(k) clearance on 1986-05-29, under 510(k) number K861638.

Who is the listed applicant for KINETIC ALKALINE PHOSPHATASE REAGENT KIT?

The FDA 510(k) record lists Bio-Analytics Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KINETIC ALKALINE PHOSPHATASE REAGENT KIT?

The FDA product code for KINETIC ALKALINE PHOSPHATASE REAGENT KIT is CJE.

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Other records listing Bio-Analytics Laboratories, Inc. as applicant

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Related Devices (Code: 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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