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FDA 510(k)

KRONUS INSULIN AUTOANTIBODY (IAA) ASSAY KIT

K-Number: K070183 · 2007-07-13

ApplicantKronus Market Development Associates, Inc.
Decision Date2007-07-13
Product CodeOCN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

KRONUS INSULIN AUTOANTIBODY (IAA) 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 2007-07-13 under 510(k) number K070183. The device is classified under product code OCN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KRONUS INSULIN AUTOANTIBODY (IAA) ASSAY KIT?

KRONUS INSULIN AUTOANTIBODY (IAA) ASSAY KIT is a medical device that received FDA 510(k) clearance on 2007-07-13. The listed applicant is Kronus Market Development Associates, Inc.. The 510(k) number is K070183.

When did KRONUS INSULIN AUTOANTIBODY (IAA) ASSAY KIT receive FDA 510(k) clearance?

KRONUS INSULIN AUTOANTIBODY (IAA) ASSAY KIT received FDA 510(k) clearance on 2007-07-13, under 510(k) number K070183.

Who is the listed applicant for KRONUS INSULIN AUTOANTIBODY (IAA) 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 KRONUS INSULIN AUTOANTIBODY (IAA) ASSAY KIT?

The FDA product code for KRONUS INSULIN AUTOANTIBODY (IAA) ASSAY KIT is OCN.

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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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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.

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