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FDA 510(k)

REAGENTS FOR DETERM. ALKALINE PHOSPHATAS

K-Number: K800679 · 1980-05-28

ApplicantDiagnostic Solutions, Inc.
Decision Date1980-05-28
Product CodeCJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

REAGENTS FOR DETERM. ALKALINE PHOSPHATAS is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Solutions, Inc.. It received FDA 510(k) clearance on 1980-05-28 under 510(k) number K800679. 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 REAGENTS FOR DETERM. ALKALINE PHOSPHATAS?

REAGENTS FOR DETERM. ALKALINE PHOSPHATAS is a medical device that received FDA 510(k) clearance on 1980-05-28. The listed applicant is Diagnostic Solutions, Inc.. The 510(k) number is K800679.

When did REAGENTS FOR DETERM. ALKALINE PHOSPHATAS receive FDA 510(k) clearance?

REAGENTS FOR DETERM. ALKALINE PHOSPHATAS received FDA 510(k) clearance on 1980-05-28, under 510(k) number K800679.

Who is the listed applicant for REAGENTS FOR DETERM. ALKALINE PHOSPHATAS?

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

What is the FDA product code for REAGENTS FOR DETERM. ALKALINE PHOSPHATAS?

The FDA product code for REAGENTS FOR DETERM. ALKALINE PHOSPHATAS is CJE.

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Other records listing Diagnostic Solutions, 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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