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FDA 510(k)

API 20E REAGENT QC

K-Number: K791222 · 1979-08-22

Decision Date1979-08-22
Product CodeJSE
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

API 20E REAGENT QC is the device name listed in this FDA 510(k) record. The listed applicant is Analytical Products, Inc.. It received FDA 510(k) clearance on 1979-08-22 under 510(k) number K791222. The device is classified under product code JSE. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the API 20E REAGENT QC?

API 20E REAGENT QC is a medical device that received FDA 510(k) clearance on 1979-08-22. The listed applicant is Analytical Products, Inc.. The 510(k) number is K791222.

When did API 20E REAGENT QC receive FDA 510(k) clearance?

API 20E REAGENT QC received FDA 510(k) clearance on 1979-08-22, under 510(k) number K791222.

Who is the listed applicant for API 20E REAGENT QC?

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

What is the FDA product code for API 20E REAGENT QC?

The FDA product code for API 20E REAGENT QC is JSE.

Related Clinical Trials

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.

Other records listing Analytical Products, 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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Related Devices (Code: JSE)

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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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