FDA 510(k)

ANTI RNA POLYMERASE III ELISA KIT, MODEL 7805

K-Number: K060431 · 2006-06-19

Decision Date2006-06-19

Product CodeNYO

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

ANTI RNA POLYMERASE III ELISA KIT, MODEL 7805 is the device name listed in this FDA 510(k) record. The listed applicant is Mbl International Corporation. It received FDA 510(k) clearance on 2006-06-19 under 510(k) number K060431. The device is classified under product code NYO. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANTI RNA POLYMERASE III ELISA KIT, MODEL 7805?

ANTI RNA POLYMERASE III ELISA KIT, MODEL 7805 is a medical device that received FDA 510(k) clearance on 2006-06-19. The listed applicant is Mbl International Corporation. The 510(k) number is K060431.

When did ANTI RNA POLYMERASE III ELISA KIT, MODEL 7805 receive FDA 510(k) clearance?

ANTI RNA POLYMERASE III ELISA KIT, MODEL 7805 received FDA 510(k) clearance on 2006-06-19, under 510(k) number K060431.

Who is the listed applicant for ANTI RNA POLYMERASE III ELISA KIT, MODEL 7805?

The FDA 510(k) record lists Mbl International Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ANTI RNA POLYMERASE III ELISA KIT, MODEL 7805?

The FDA product code for ANTI RNA POLYMERASE III ELISA KIT, MODEL 7805 is NYO.

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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.