FDA 510(k)

CLEVER CHEK TD-3213

K-Number: K042795 · 2005-03-07

Decision Date2005-03-07

Product CodeNBW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

CLEVER CHEK TD-3213 is the device name listed in this FDA 510(k) record. The listed applicant is Taidoc Technology Corporation. It received FDA 510(k) clearance on 2005-03-07 under 510(k) number K042795. The device is classified under product code NBW. It was reviewed by the CH advisory panel. Product code NBW falls under the category of OB/GYN, which includes obstetric and gynecological diagnostic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLEVER CHEK TD-3213?

CLEVER CHEK TD-3213 is a medical device that received FDA 510(k) clearance on 2005-03-07. The listed applicant is Taidoc Technology Corporation. The 510(k) number is K042795.

When did CLEVER CHEK TD-3213 receive FDA 510(k) clearance?

CLEVER CHEK TD-3213 received FDA 510(k) clearance on 2005-03-07, under 510(k) number K042795.

Who is the listed applicant for CLEVER CHEK TD-3213?

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

What is the FDA product code for CLEVER CHEK TD-3213?

The FDA product code for CLEVER CHEK TD-3213 is NBW. This falls under the OB/GYN category.

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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.