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FDA 510(k)

ALKALINE PHOSPHATASE REAGENT SET

K-Number: K880307 · 1988-03-15

ApplicantTech-Neal Scientific, Inc.
Decision Date1988-03-15
Product CodeCJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALKALINE PHOSPHATASE REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Tech-Neal Scientific, Inc.. It received FDA 510(k) clearance on 1988-03-15 under 510(k) number K880307. 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 REAGENT SET?

ALKALINE PHOSPHATASE REAGENT SET is a medical device that received FDA 510(k) clearance on 1988-03-15. The listed applicant is Tech-Neal Scientific, Inc.. The 510(k) number is K880307.

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

ALKALINE PHOSPHATASE REAGENT SET received FDA 510(k) clearance on 1988-03-15, under 510(k) number K880307.

Who is the listed applicant for ALKALINE PHOSPHATASE REAGENT SET?

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

What is the FDA product code for ALKALINE PHOSPHATASE REAGENT SET?

The FDA product code for ALKALINE PHOSPHATASE REAGENT SET is CJE.

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Other records listing Tech-Neal Scientific, 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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