FDA 510(k)

PRECINORM CK-MB AND PRECIPATH CK-MB CONTROLS

K-Number: K062972 · 2006-10-13

Decision Date2006-10-13

Product CodeJJX

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

PRECINORM CK-MB AND PRECIPATH CK-MB CONTROLS is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Corp.. It received FDA 510(k) clearance on 2006-10-13 under 510(k) number K062972. 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 PRECINORM CK-MB AND PRECIPATH CK-MB CONTROLS?

PRECINORM CK-MB AND PRECIPATH CK-MB CONTROLS is a medical device that received FDA 510(k) clearance on 2006-10-13. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K062972.

When did PRECINORM CK-MB AND PRECIPATH CK-MB CONTROLS receive FDA 510(k) clearance?

PRECINORM CK-MB AND PRECIPATH CK-MB CONTROLS received FDA 510(k) clearance on 2006-10-13, under 510(k) number K062972.

Who is the listed applicant for PRECINORM CK-MB AND PRECIPATH CK-MB CONTROLS?

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

What is the FDA product code for PRECINORM CK-MB AND PRECIPATH CK-MB CONTROLS?

The FDA product code for PRECINORM CK-MB AND PRECIPATH CK-MB CONTROLS 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 Roche Diagnostics Corp. as applicant

K130138SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEM K101365ELECSYS CA 19-9 CALCHECK 5 K100853COBAS 8000 MODULAR SERIES ANALYZER K101196ACCU-CHEK ULTRFLEX INFUSION SET K093664AMPHETAMINES II ASSAY K101075ELECSYS INSULIN CALCHECK 5

View all 263 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.