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FDA 510(k)

KRONUS BLOCKING ACETYLCHOLINE RECEPTOR AUTOANTIBODY (ACHRAB) RIA ASSAY KIT

K-Number: K080523 · 2008-06-17

ApplicantKronus Market Development Associates, Inc.
Decision Date2008-06-17
Product CodeNST
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

KRONUS BLOCKING ACETYLCHOLINE RECEPTOR AUTOANTIBODY (ACHRAB) RIA 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 2008-06-17 under 510(k) number K080523. The device is classified under product code NST. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KRONUS BLOCKING ACETYLCHOLINE RECEPTOR AUTOANTIBODY (ACHRAB) RIA ASSAY KIT?

KRONUS BLOCKING ACETYLCHOLINE RECEPTOR AUTOANTIBODY (ACHRAB) RIA ASSAY KIT is a medical device that received FDA 510(k) clearance on 2008-06-17. The listed applicant is Kronus Market Development Associates, Inc.. The 510(k) number is K080523.

When did KRONUS BLOCKING ACETYLCHOLINE RECEPTOR AUTOANTIBODY (ACHRAB) RIA ASSAY KIT receive FDA 510(k) clearance?

KRONUS BLOCKING ACETYLCHOLINE RECEPTOR AUTOANTIBODY (ACHRAB) RIA ASSAY KIT received FDA 510(k) clearance on 2008-06-17, under 510(k) number K080523.

Who is the listed applicant for KRONUS BLOCKING ACETYLCHOLINE RECEPTOR AUTOANTIBODY (ACHRAB) RIA 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 BLOCKING ACETYLCHOLINE RECEPTOR AUTOANTIBODY (ACHRAB) RIA ASSAY KIT?

The FDA product code for KRONUS BLOCKING ACETYLCHOLINE RECEPTOR AUTOANTIBODY (ACHRAB) RIA ASSAY KIT is NST.

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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 KITK080159KRONUS TSH RECEPTOR AUTOANTIBODY (TRAB) ELISA ASSAY KITK073590KRONUS IA-2 AUTOANTIBODY RIA ASSAY KITK072135KRONUS GAD AUTOANTIBODY ELISA ASSAY KITK070183KRONUS INSULIN AUTOANTIBODY (IAA) ASSAY KIT

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Related Devices (Code: NST)

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.

K091468IVD TECHNOLOGIES ACHRAB TEST KITIvd TechnologiesK051144ACETYLCHOLINE RECEPTOR AB (ARAB)RRAIbl-Hamburg GmbHK042248KRONUS, INC.'S ACETYLCHOLINE RECEPTOR ANTIBODY (ACHRAB) ASSAY KITKronus Market Development Associates, Inc.

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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