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FDA 510(k)

TSH RECEPTOR ANTIBODY (TRAB) COATED TUBE (CT) ASSAY KIT

K-Number: K032134 · 2003-09-10

ApplicantKronus Market Development Associates, Inc.
Decision Date2003-09-10
Product CodeJZO
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

TSH RECEPTOR ANTIBODY (TRAB) COATED TUBE (CT) ASSAY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Kronus Market Development Associates, Inc.. It received FDA 510(k) clearance on 2003-09-10 under 510(k) number K032134. 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 TSH RECEPTOR ANTIBODY (TRAB) COATED TUBE (CT) ASSAY KIT?

TSH RECEPTOR ANTIBODY (TRAB) COATED TUBE (CT) ASSAY KIT is a medical device that received FDA 510(k) clearance on 2003-09-10. The listed applicant is Kronus Market Development Associates, Inc.. The 510(k) number is K032134.

When did TSH RECEPTOR ANTIBODY (TRAB) COATED TUBE (CT) ASSAY KIT receive FDA 510(k) clearance?

TSH RECEPTOR ANTIBODY (TRAB) COATED TUBE (CT) ASSAY KIT received FDA 510(k) clearance on 2003-09-10, under 510(k) number K032134.

Who is the listed applicant for TSH RECEPTOR ANTIBODY (TRAB) COATED TUBE (CT) ASSAY KIT?

The FDA 510(k) record lists Kronus Market Development Associates, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TSH RECEPTOR ANTIBODY (TRAB) COATED TUBE (CT) ASSAY KIT?

The FDA product code for TSH RECEPTOR ANTIBODY (TRAB) COATED TUBE (CT) ASSAY KIT is JZO.

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Other records listing Kronus Market Development Associates, 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.

K121046STEROID 21-HYDROXYLASE ANTIBODY (21-OHAB) RIA ASSAY KITK111956KRONUS VOLTAGE GATED CALCIUM CHANNEL (VGCC) ANTIBODY RIA ASSAY KITK080523KRONUS BLOCKING ACETYLCHOLINE RECEPTOR AUTOANTIBODY (ACHRAB) RIA ASSAY KITK080159KRONUS TSH RECEPTOR AUTOANTIBODY (TRAB) ELISA ASSAY KITK073590KRONUS IA-2 AUTOANTIBODY RIA ASSAY KITK072135KRONUS GAD AUTOANTIBODY ELISA ASSAY KIT

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Related Devices (Code: JZO)

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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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