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FDA 510(k)

KETOREX C SANWA

K-Number: K953452 · 1996-05-02

ApplicantIhara Medics U.S., Inc.
Decision Date1996-05-02
Product CodeJMK
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

KETOREX C SANWA is the device name listed in this FDA 510(k) record. The listed applicant is Ihara Medics U.S., Inc.. It received FDA 510(k) clearance on 1996-05-02 under 510(k) number K953452. The device is classified under product code JMK. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KETOREX C SANWA?

KETOREX C SANWA is a medical device that received FDA 510(k) clearance on 1996-05-02. The listed applicant is Ihara Medics U.S., Inc.. The 510(k) number is K953452.

When did KETOREX C SANWA receive FDA 510(k) clearance?

KETOREX C SANWA received FDA 510(k) clearance on 1996-05-02, under 510(k) number K953452.

Who is the listed applicant for KETOREX C SANWA?

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

What is the FDA product code for KETOREX C SANWA?

The FDA product code for KETOREX C SANWA is JMK.

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 Ihara Medics U.S., 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.

K912373KETO-340 IIK903365KETOREX SANWA STANDARDSK903366KETONE TEST B SANWA STANDARDK903367KETONE TEST A SANWA STANDARD

Related Devices (Code: JMK)

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.

K983860MTM BIOSCANNER K TEST STRIPS, CAT # BSA610Polymer Technology Systems, Inc.K981865MTM BIOSCANNER K TEST STRIPSPolymer Technology Systems, Inc.K941427SERUM @-HYDROXYBUTYRATE DEHYDROGENASE (HBDH)Teco DiagnosticsK862319HBDH (OPTIMIZED) REAGENTSigma Chemical Co.K843774RAICHEM X-HBDH REAGENTReagents Applications, Inc.K822739AHBDGilford Diagnostics

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.

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