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FDA 510(k)

THYRETAIN TM TSI REPORTER BIOASSAY

K-Number: K092229 · 2010-05-18

ApplicantDiagnostic Hybrids, Inc.
Decision Date2010-05-18
Product CodeJZO
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

THYRETAIN TM TSI REPORTER BIOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Hybrids, Inc.. It received FDA 510(k) clearance on 2010-05-18 under 510(k) number K092229. The device is classified under product code JZO. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THYRETAIN TM TSI REPORTER BIOASSAY?

THYRETAIN TM TSI REPORTER BIOASSAY is a medical device that received FDA 510(k) clearance on 2010-05-18. The listed applicant is Diagnostic Hybrids, Inc.. The 510(k) number is K092229.

When did THYRETAIN TM TSI REPORTER BIOASSAY receive FDA 510(k) clearance?

THYRETAIN TM TSI REPORTER BIOASSAY received FDA 510(k) clearance on 2010-05-18, under 510(k) number K092229.

Who is the listed applicant for THYRETAIN TM TSI REPORTER BIOASSAY?

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

What is the FDA product code for THYRETAIN TM TSI REPORTER BIOASSAY?

The FDA product code for THYRETAIN TM TSI REPORTER BIOASSAY is JZO.

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Related Devices (Code: JZO)

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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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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