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)

CK-MB METHOD FOR THE TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEM

K-Number: K950186 · 1995-03-13

ApplicantMiles, Inc.
Decision Date1995-03-13
Product CodeJHW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CK-MB METHOD FOR THE TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Miles, Inc.. It received FDA 510(k) clearance on 1995-03-13 under 510(k) number K950186. The device is classified under product code JHW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CK-MB METHOD FOR THE TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEM?

CK-MB METHOD FOR THE TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEM is a medical device that received FDA 510(k) clearance on 1995-03-13. The listed applicant is Miles, Inc.. The 510(k) number is K950186.

When did CK-MB METHOD FOR THE TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEM receive FDA 510(k) clearance?

CK-MB METHOD FOR THE TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEM received FDA 510(k) clearance on 1995-03-13, under 510(k) number K950186.

Who is the listed applicant for CK-MB METHOD FOR THE TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEM?

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

What is the FDA product code for CK-MB METHOD FOR THE TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEM?

The FDA product code for CK-MB METHOD FOR THE TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEM is JHW.

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 Miles, Inc. 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.

K950292FOLATE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM, IN VITRO DIAGNOSTIC SYSTEMK950353TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEMK945655CREATININE (ENZYMATIC UV) PROCEDURE FOR TECHNICON SYSTEMS (IN VITRO DIAGNOSTIC TEST SYSTEM)K941171TECHNICON H* 3 RTC SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM)K943376OPERA SYSTEMK941156TECHNISON AXON SYSTEM

View all 11 devices →

Related Devices (Code: JHW)

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.

K162526Creatine Kinase-MBRoche DiagnosticsK122083ELITECH CLINICAL SYSTEMS CK NAC SLElitechgroupK023744WIENER LAB. CK-MB DS UV UNITEST, MODEL 28 X 2.5 ML CAT. NR. 1271354Wiener Laboratories SaicK003158ROCHE DIAGNOSTICS CK-MBRoche Diagnostics Corp.K961501ELECSYS CK-MBBoehringer Mannheim Corp.K944325LIFESIGN, CARE POINT, VITALSIGN, ACCUSIGNPrinceton BioMeditech Corp.

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.

↑