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FDA 510(k)

QAB2A IGM ELISA KIT

K-Number: K020694 · 2002-04-19

Decision Date2002-04-19
Product CodeMVS
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

QAB2A IGM ELISA KIT is the device name listed in this FDA 510(k) record. The listed applicant is Cheshire Diagnostics , Ltd.. It received FDA 510(k) clearance on 2002-04-19 under 510(k) number K020694. The device is classified under product code MVS. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QAB2A IGM ELISA KIT?

QAB2A IGM ELISA KIT is a medical device that received FDA 510(k) clearance on 2002-04-19. The listed applicant is Cheshire Diagnostics , Ltd.. The 510(k) number is K020694.

When did QAB2A IGM ELISA KIT receive FDA 510(k) clearance?

QAB2A IGM ELISA KIT received FDA 510(k) clearance on 2002-04-19, under 510(k) number K020694.

Who is the listed applicant for QAB2A IGM ELISA KIT?

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

What is the FDA product code for QAB2A IGM ELISA KIT?

The FDA product code for QAB2A IGM ELISA KIT is MVS.

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 Cheshire Diagnostics , Ltd. 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.

Official Source

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