Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ARCHITECT SHBG

K-Number: K152185 · 2016-02-11

ApplicantBiokit, S.A.
Decision Date2016-02-11
Product CodeCDZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ARCHITECT SHBG is the device name listed in this FDA 510(k) record. The listed applicant is Biokit, S.A.. It received FDA 510(k) clearance on 2016-02-11 under 510(k) number K152185. The device is classified under product code CDZ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARCHITECT SHBG?

ARCHITECT SHBG is a medical device that received FDA 510(k) clearance on 2016-02-11. The listed applicant is Biokit, S.A.. The 510(k) number is K152185.

When did ARCHITECT SHBG receive FDA 510(k) clearance?

ARCHITECT SHBG received FDA 510(k) clearance on 2016-02-11, under 510(k) number K152185.

Who is the listed applicant for ARCHITECT SHBG?

The FDA 510(k) record lists Biokit, S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARCHITECT SHBG?

The FDA product code for ARCHITECT SHBG is CDZ.

Other records listing Biokit, S.A. 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.

K243575ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG ControlsK233606ADVIA Centaur EBV-VCA IgMK233605ADVIA Centaur EBV-EBNA IgGK213987ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG ControlsK214068Quantia IgEK181334ADVIA Centaur Herpes-2 IgG

View all 8 devices →

Related Devices (Code: CDZ)

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.

K252728IDS-iSYS Total TestosteroneImmunodiagnostic Systems LimitedK240865IDS-iSYS Free TestosteroneImmunodiagnostic Systems LimitedK233480Access SHBGBeckman Coulter, Inc.K223405Access TestosteroneBeckman Coulter, Inc.K211685Elecsys Testosterone IIRoche DiagnosticsK201908LIAISON Testosterone xtDiaSorin, 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.

↑