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FDA 510(k)

STEROID 21-HYDROXYLASE ANTIBODY (21-OHAB) RIA ASSAY KIT

K-Number: K121046 · 2012-12-20

ApplicantKronus Market Development Associates, Inc.
Decision Date2012-12-20
Product CodePCG
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

STEROID 21-HYDROXYLASE ANTIBODY (21-OHAB) 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 2012-12-20 under 510(k) number K121046. The device is classified under product code PCG. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STEROID 21-HYDROXYLASE ANTIBODY (21-OHAB) RIA ASSAY KIT?

STEROID 21-HYDROXYLASE ANTIBODY (21-OHAB) RIA ASSAY KIT is a medical device that received FDA 510(k) clearance on 2012-12-20. The listed applicant is Kronus Market Development Associates, Inc.. The 510(k) number is K121046.

When did STEROID 21-HYDROXYLASE ANTIBODY (21-OHAB) RIA ASSAY KIT receive FDA 510(k) clearance?

STEROID 21-HYDROXYLASE ANTIBODY (21-OHAB) RIA ASSAY KIT received FDA 510(k) clearance on 2012-12-20, under 510(k) number K121046.

Who is the listed applicant for STEROID 21-HYDROXYLASE ANTIBODY (21-OHAB) 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 STEROID 21-HYDROXYLASE ANTIBODY (21-OHAB) RIA ASSAY KIT?

The FDA product code for STEROID 21-HYDROXYLASE ANTIBODY (21-OHAB) RIA ASSAY KIT is PCG.

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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.

K111956KRONUS 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 KITK070183KRONUS INSULIN AUTOANTIBODY (IAA) ASSAY KIT

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Related Devices (Code: PCG)

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.

K180607Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA KitKronus, 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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