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FDA 510(k)

ALKALINE PHOSPHATASE-SL ASSAY, MODELS 328-17 AND 328-30

K-Number: K003093 · 2000-11-27

ApplicantDiagnostic Chemicals , Ltd.
Decision Date2000-11-27
Product CodeCJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALKALINE PHOSPHATASE-SL ASSAY, MODELS 328-17 AND 328-30 is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Chemicals , Ltd.. It received FDA 510(k) clearance on 2000-11-27 under 510(k) number K003093. 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-SL ASSAY, MODELS 328-17 AND 328-30?

ALKALINE PHOSPHATASE-SL ASSAY, MODELS 328-17 AND 328-30 is a medical device that received FDA 510(k) clearance on 2000-11-27. The listed applicant is Diagnostic Chemicals , Ltd.. The 510(k) number is K003093.

When did ALKALINE PHOSPHATASE-SL ASSAY, MODELS 328-17 AND 328-30 receive FDA 510(k) clearance?

ALKALINE PHOSPHATASE-SL ASSAY, MODELS 328-17 AND 328-30 received FDA 510(k) clearance on 2000-11-27, under 510(k) number K003093.

Who is the listed applicant for ALKALINE PHOSPHATASE-SL ASSAY, MODELS 328-17 AND 328-30?

The FDA 510(k) record lists Diagnostic Chemicals , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALKALINE PHOSPHATASE-SL ASSAY, MODELS 328-17 AND 328-30?

The FDA product code for ALKALINE PHOSPHATASE-SL ASSAY, MODELS 328-17 AND 328-30 is 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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