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 I THEOPHYLLINE REAGENTS AND CALIBRATORS (A-F)

K-Number: K070810 · 2007-06-08

ApplicantBiokit, S.A.
Decision Date2007-06-08
Product CodeLGS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ARCHITECT I THEOPHYLLINE REAGENTS AND CALIBRATORS (A-F) 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 2007-06-08 under 510(k) number K070810. The device is classified under product code LGS. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARCHITECT I THEOPHYLLINE REAGENTS AND CALIBRATORS (A-F)?

ARCHITECT I THEOPHYLLINE REAGENTS AND CALIBRATORS (A-F) is a medical device that received FDA 510(k) clearance on 2007-06-08. The listed applicant is Biokit, S.A.. The 510(k) number is K070810.

When did ARCHITECT I THEOPHYLLINE REAGENTS AND CALIBRATORS (A-F) receive FDA 510(k) clearance?

ARCHITECT I THEOPHYLLINE REAGENTS AND CALIBRATORS (A-F) received FDA 510(k) clearance on 2007-06-08, under 510(k) number K070810.

Who is the listed applicant for ARCHITECT I THEOPHYLLINE REAGENTS AND CALIBRATORS (A-F)?

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 I THEOPHYLLINE REAGENTS AND CALIBRATORS (A-F)?

The FDA product code for ARCHITECT I THEOPHYLLINE REAGENTS AND CALIBRATORS (A-F) is LGS.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 23 devices →

Related Devices (Code: LGS)

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.

K955567INNOFLUOR THEOPHYLLINE ASSAY SYSTEMOxis Intl., Inc.K953016AXSYM THEOPHYLLINE IIAbbott LaboratoriesK951169CIBA CORINING ACS THEOPHYLLINE IMMUNOASSAYCiba Corning Diagnostics Corp.K942991QMS THEOPHYLLINE CSSeradyn, Inc.K932127TDX/TDXFLX & TDXFLX THEOPHYLLINE MONOCLONAL IIAbbott LaboratoriesK922991ABBOTT TDX/TDXFLX AND TDXFLX THEOPHYLLINEAbbott Laboratories

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.

↑