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FDA 510(k)

HVA EIA KIT YAMASA

K-Number: K895288 · 1989-10-31

ApplicantYamasa Shoy Co., Ltd.
Decision Date1989-10-31
Product CodeCDF
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HVA EIA KIT YAMASA is the device name listed in this FDA 510(k) record. The listed applicant is Yamasa Shoy Co., Ltd.. It received FDA 510(k) clearance on 1989-10-31 under 510(k) number K895288. The device is classified under product code CDF. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HVA EIA KIT YAMASA?

HVA EIA KIT YAMASA is a medical device that received FDA 510(k) clearance on 1989-10-31. The listed applicant is Yamasa Shoy Co., Ltd.. The 510(k) number is K895288.

When did HVA EIA KIT YAMASA receive FDA 510(k) clearance?

HVA EIA KIT YAMASA received FDA 510(k) clearance on 1989-10-31, under 510(k) number K895288.

Who is the listed applicant for HVA EIA KIT YAMASA?

The FDA 510(k) record lists Yamasa Shoy Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HVA EIA KIT YAMASA?

The FDA product code for HVA EIA KIT YAMASA is CDF.

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 Yamasa Shoy Co., Ltd. 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.

K895287VMA EIA KIT YAMASA

Related Devices (Code: CDF)

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.

K953077PARAGON CZE 2000 CLINICAL CAPILLARY ELECTROPHORESIS SYSTEMBeckman Instruments, Inc.K934977MODEL 5500 CEASEsa, Inc.K895287VMA EIA KIT YAMASAYamasa Shoy Co., Ltd.K873372HVA & HOMOVANILLIC ACID BY HPLC METHODBio-RadK861962VANILMANDELIC ACID (VMA) REAGENT SETSterling Diagnostics, Inc.K861010VMA BY HPLC TEST (VANILMANDELIC ACID)Bio-Rad

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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