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FDA 510(k)

PROFIBLOT

K-Number: K933996 · 1994-01-28

ApplicantTecan U.S., Ltd.
Decision Date1994-01-28
Product CodeKPA
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

PROFIBLOT is the device name listed in this FDA 510(k) record. The listed applicant is Tecan U.S., Ltd.. It received FDA 510(k) clearance on 1994-01-28 under 510(k) number K933996. 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 PROFIBLOT?

PROFIBLOT is a medical device that received FDA 510(k) clearance on 1994-01-28. The listed applicant is Tecan U.S., Ltd.. The 510(k) number is K933996.

When did PROFIBLOT receive FDA 510(k) clearance?

PROFIBLOT received FDA 510(k) clearance on 1994-01-28, under 510(k) number K933996.

Who is the listed applicant for PROFIBLOT?

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

What is the FDA product code for PROFIBLOT?

The FDA product code for PROFIBLOT 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 Tecan U.S., 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.

K915492RSP MEGA SAMPLE PROCESSORK912036ROBOTIC SAMPLE PROCESSORK910740SLT MICROPLATE WASHERK894126ROBOTIC SAMPLE PROCESSORK854406TECAN ROBOTIC SAMPLE PROCESSOR(RSP) #500

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.

K884258VERSABLOTAmerican Bionetics, Inc.K881592WESCOR MODEL 7300 AEROSPRAY GRAM STAINERWescor, Inc.K880745LX-100 SLIDE STAINERInnovative Medical Systems, Inc.K874887WESBLOT PROCESSORAmerican Bionetics, Inc.K874897SAKURA DRS-60 AUTOMATIC SLIDE STAINERSakura Finetek U.S.A., Inc.K872916HISTOMATIC SLIDE STAINER, CODE-ON VERSIONFisher Scientific Co., LLC

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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