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FDA 510(k)

CHEMPRO 1000

K-Number: K854260 · 1985-11-19

ApplicantSen Tech Medical Corp.
Decision Date1985-11-19
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHEMPRO 1000 is the device name listed in this FDA 510(k) record. The listed applicant is Sen Tech Medical Corp.. It received FDA 510(k) clearance on 1985-11-19 under 510(k) number K854260. The device is classified under product code CGA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHEMPRO 1000?

CHEMPRO 1000 is a medical device that received FDA 510(k) clearance on 1985-11-19. The listed applicant is Sen Tech Medical Corp.. The 510(k) number is K854260.

When did CHEMPRO 1000 receive FDA 510(k) clearance?

CHEMPRO 1000 received FDA 510(k) clearance on 1985-11-19, under 510(k) number K854260.

Who is the listed applicant for CHEMPRO 1000?

The FDA 510(k) record lists Sen Tech Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CHEMPRO 1000?

The FDA product code for CHEMPRO 1000 is CGA.

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 Sen Tech Medical Corp. 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.

K910071PORTA GAS COMPRESSED GAS CYLINDER CARTK855091CHEM-PRO 1000 CLINICAL CHEMISTRY-ANALYSIS SYSK851100CHEM PRO 1000 CHEMISTRY ANALYSISK841575SENTECH'S ULAB 1000 CLINICAL CHEM.

Related Devices (Code: CGA)

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.

K252488ABL90 FLEX PLUS SystemRadiometer Medicals ApsK210933YSI 2900C Biochemistry AnalyzerYsi, Inc.K220328EasyStat 300Medica CorporationK223179Cholestech LDX ™ SystemAlere San Diego, Inc.K223755i-STAT G cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K223710i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.

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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