FDA 510(k)

IMMULITE/IMMULITE 1000 PROGESTERONE CALIBRATION VERIFICATION (CVM)

K-Number: K103683 · 2011-04-28

Decision Date2011-04-28

Product CodeJJX

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

IMMULITE/IMMULITE 1000 PROGESTERONE CALIBRATION VERIFICATION (CVM) is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics. It received FDA 510(k) clearance on 2011-04-28 under 510(k) number K103683. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMULITE/IMMULITE 1000 PROGESTERONE CALIBRATION VERIFICATION (CVM)?

IMMULITE/IMMULITE 1000 PROGESTERONE CALIBRATION VERIFICATION (CVM) is a medical device that received FDA 510(k) clearance on 2011-04-28. The listed applicant is Siemens Healthcare Diagnostics. The 510(k) number is K103683.

When did IMMULITE/IMMULITE 1000 PROGESTERONE CALIBRATION VERIFICATION (CVM) receive FDA 510(k) clearance?

IMMULITE/IMMULITE 1000 PROGESTERONE CALIBRATION VERIFICATION (CVM) received FDA 510(k) clearance on 2011-04-28, under 510(k) number K103683.

Who is the listed applicant for IMMULITE/IMMULITE 1000 PROGESTERONE CALIBRATION VERIFICATION (CVM)?

The FDA 510(k) record lists Siemens Healthcare Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMMULITE/IMMULITE 1000 PROGESTERONE CALIBRATION VERIFICATION (CVM)?

The FDA product code for IMMULITE/IMMULITE 1000 PROGESTERONE CALIBRATION VERIFICATION (CVM) is JJX.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Siemens Healthcare Diagnostics as applicant

K243570Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L)K162977ADVIA 2120i, ADVIA 2120 K162298LOCI Total Vitamin D Total Assay, LOCI VITD CAL K161954Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc)K162538ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator K151964Xprecia Stride Coagulation System, Xprecia System PT Controls

View all 85 devices →

Related Devices (Code: JJX)

K170678Beta-CrossLaps CalCheck 5Roche Diagnostics K162173Elecsys CYFRA 21-1 CalCheck 5Roche Diagnostics K162514Multichem A1cTechnopath Manufacturing K161874Audit MicroControls Linearity DROP LQ Blood GlucoseAalto Scientific, Ltd.K161526LIAISON CMV IgM Serum Control SetDiaSorin, Inc.K161522LIAISON EBV IgM Serum Control SetDiaSorin, 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.