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FDA 510(k)

SAKURA DRS-60 AUTOMATIC SLIDE STAINER

K-Number: K874897 · 1988-01-05

ApplicantSakura Finetek U.S.A., Inc.
Decision Date1988-01-05
Product CodeKPA
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

SAKURA DRS-60 AUTOMATIC SLIDE STAINER is the device name listed in this FDA 510(k) record. The listed applicant is Sakura Finetek U.S.A., Inc.. It received FDA 510(k) clearance on 1988-01-05 under 510(k) number K874897. The device is classified under product code KPA. It was reviewed by the PA advisory panel. Product code KPA falls under the category of Cardiovascular, which encompasses devices for cardiovascular diagnosis, monitoring, and intervention. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAKURA DRS-60 AUTOMATIC SLIDE STAINER?

SAKURA DRS-60 AUTOMATIC SLIDE STAINER is a medical device that received FDA 510(k) clearance on 1988-01-05. The listed applicant is Sakura Finetek U.S.A., Inc.. The 510(k) number is K874897.

When did SAKURA DRS-60 AUTOMATIC SLIDE STAINER receive FDA 510(k) clearance?

SAKURA DRS-60 AUTOMATIC SLIDE STAINER received FDA 510(k) clearance on 1988-01-05, under 510(k) number K874897.

Who is the listed applicant for SAKURA DRS-60 AUTOMATIC SLIDE STAINER?

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

What is the FDA product code for SAKURA DRS-60 AUTOMATIC SLIDE STAINER?

The FDA product code for SAKURA DRS-60 AUTOMATIC SLIDE STAINER is KPA. This falls under the Cardiovascular category.

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 Sakura Finetek U.S.A., 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.

K893811SAKURA PREP AI AUTOMATIC LIQUID HANDLING SYSTEMK882881SAKURA-MEDSCAND SCA-1800 AUTOMATIC COVERSLIPPERK881165SAKURA HEM-480 ELECTRON MICROSCOPY PROCESSOR

Related Devices (Code: KPA)

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.

K933996PROFIBLOTTecan U.S., Ltd.K884258VERSABLOTAmerican Bionetics, Inc.K881592WESCOR MODEL 7300 AEROSPRAY GRAM STAINERWescor, Inc.K880745LX-100 SLIDE STAINERInnovative Medical Systems, Inc.K874887WESBLOT PROCESSORAmerican Bionetics, Inc.K872916HISTOMATIC SLIDE STAINER, CODE-ON VERSIONFisher Scientific Co., LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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