FDA 510(k)

CEDIA CORE TDM MULTI-CAL

K-Number: K961659 · 1996-06-13

Decision Date1996-06-13

Product CodeJIX

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

CEDIA CORE TDM MULTI-CAL is the device name listed in this FDA 510(k) record. The listed applicant is Boehringer Mannheim Corp.. It received FDA 510(k) clearance on 1996-06-13 under 510(k) number K961659. The device is classified under product code JIX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CEDIA CORE TDM MULTI-CAL?

CEDIA CORE TDM MULTI-CAL is a medical device that received FDA 510(k) clearance on 1996-06-13. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K961659.

When did CEDIA CORE TDM MULTI-CAL receive FDA 510(k) clearance?

CEDIA CORE TDM MULTI-CAL received FDA 510(k) clearance on 1996-06-13, under 510(k) number K961659.

Who is the listed applicant for CEDIA CORE TDM MULTI-CAL?

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

What is the FDA product code for CEDIA CORE TDM MULTI-CAL?

The FDA product code for CEDIA CORE TDM MULTI-CAL is JIX.

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 Boehringer Mannheim Corp. as applicant

K984326ELECYS IGE ASSAY K983047ACCU-CHEK HQ SYSTEM K984419ELECSYS IGE CALCHECK K984425MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATOR K984372ELECSYS CALCHECK TROPONIN T K984105ELECSYS TROPONIN T STAT TEST

View all 340 devices →

Related Devices (Code: JIX)

K161140VITROS Chemistry Products Calibrator Kit 3Ortho-Clinical Diagnostics, Inc.K133330C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEINRoche Diagnostics K130765ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL IIElitechgroup K123321DIMENSION CHEMISTRY III CALIBRATORYSiemens Healthcare Diagnostics K123372ABBOTT LIPID MULTI CONSTITUENT CALIBRATORAbbott Laboratories K122398RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORSSiemens Healthcare Diagnostics, 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.