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FDA 510(k)

CHEM-PRO 1000 CLINICAL CHEMISTRY-ANALYSIS SYS

K-Number: K855091 · 1986-03-14

ApplicantSen Tech Medical Corp.
Decision Date1986-03-14
Product CodeCDS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHEM-PRO 1000 CLINICAL CHEMISTRY-ANALYSIS SYS 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 1986-03-14 under 510(k) number K855091. The device is classified under product code CDS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHEM-PRO 1000 CLINICAL CHEMISTRY-ANALYSIS SYS?

CHEM-PRO 1000 CLINICAL CHEMISTRY-ANALYSIS SYS is a medical device that received FDA 510(k) clearance on 1986-03-14. The listed applicant is Sen Tech Medical Corp.. The 510(k) number is K855091.

When did CHEM-PRO 1000 CLINICAL CHEMISTRY-ANALYSIS SYS receive FDA 510(k) clearance?

CHEM-PRO 1000 CLINICAL CHEMISTRY-ANALYSIS SYS received FDA 510(k) clearance on 1986-03-14, under 510(k) number K855091.

Who is the listed applicant for CHEM-PRO 1000 CLINICAL CHEMISTRY-ANALYSIS SYS?

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 CHEM-PRO 1000 CLINICAL CHEMISTRY-ANALYSIS SYS?

The FDA product code for CHEM-PRO 1000 CLINICAL CHEMISTRY-ANALYSIS SYS is CDS.

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 CARTK854260CHEMPRO 1000K851100CHEM PRO 1000 CHEMISTRY ANALYSISK841575SENTECH'S ULAB 1000 CLINICAL CHEM.

Related Devices (Code: CDS)

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.

K171247epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide TestEpocal, Inc.K040973BUN REAGENTGenchem, Inc.K033056BUN REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA REAGENTDiamond Diagnostics, Inc.K925550HI CHEM BUN REAGENT KIT,PRODUCT NUMBER 88806Hichem DiagnosticsK860543BLOOD UREA NITROGEN (BUN) TESTCARDIlex Corp.K812308LANCER BUN RATE REAGENT KITSherwood Medical Co.

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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