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FDA 510(k)

SELECTA 20/60 CHEMISTRY ANALYZER

K-Number: K942922 · 1995-07-19

ApplicantSelect Medical Systems, Inc.
Decision Date1995-07-19
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SELECTA 20/60 CHEMISTRY ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Select Medical Systems, Inc.. It received FDA 510(k) clearance on 1995-07-19 under 510(k) number K942922. The device is classified under product code JJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SELECTA 20/60 CHEMISTRY ANALYZER?

SELECTA 20/60 CHEMISTRY ANALYZER is a medical device that received FDA 510(k) clearance on 1995-07-19. The listed applicant is Select Medical Systems, Inc.. The 510(k) number is K942922.

When did SELECTA 20/60 CHEMISTRY ANALYZER receive FDA 510(k) clearance?

SELECTA 20/60 CHEMISTRY ANALYZER received FDA 510(k) clearance on 1995-07-19, under 510(k) number K942922.

Who is the listed applicant for SELECTA 20/60 CHEMISTRY ANALYZER?

The FDA 510(k) record lists Select Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SELECTA 20/60 CHEMISTRY ANALYZER?

The FDA product code for SELECTA 20/60 CHEMISTRY ANALYZER is JJE.

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 Select Medical Systems, 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.

K012935THECURVE, ITEM 507K974819SELECTCELLS(TM) MINIK954099SELECT IUIK954102SELECTMUCUSK954097SELECTCELLS STANDARD

Related Devices (Code: JJE)

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.

K183375Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride ElectrodeHoriba, Ltd.K130276DIMENSION EXL WITH LM SYSTEMSiemens Healthcare Diagnostics, Inc.K113253ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN REAGENT,ACE BUN/UREANITROGEN REAGENTAlfa Wassermann Diagnostic Technologies, Inc.K112999DIMENSION CLINICAL CHEMISTRY SYSTEMSiemens Healthcare DiagnosticsK110035INDIKOThermofisher Scientific OYK073370TC MATRIX CLINICAL CHEMISTRY ANALYZERTeco Diagnostics

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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