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FDA 510(k)

WASH SOLUTION KIT

K-Number: K873130 · 1987-10-23

ApplicantA-Kem, Inc.
Decision Date1987-10-23
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

WASH SOLUTION KIT is the device name listed in this FDA 510(k) record. The listed applicant is A-Kem, Inc.. It received FDA 510(k) clearance on 1987-10-23 under 510(k) number K873130. 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 WASH SOLUTION KIT?

WASH SOLUTION KIT is a medical device that received FDA 510(k) clearance on 1987-10-23. The listed applicant is A-Kem, Inc.. The 510(k) number is K873130.

When did WASH SOLUTION KIT receive FDA 510(k) clearance?

WASH SOLUTION KIT received FDA 510(k) clearance on 1987-10-23, under 510(k) number K873130.

Who is the listed applicant for WASH SOLUTION KIT?

The FDA 510(k) record lists A-Kem, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WASH SOLUTION KIT?

The FDA product code for WASH SOLUTION KIT 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 A-Kem, 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.

K884224TOTAL BILIRUBIN REAGENT KIT FOR ASTRA SYSTEMSK884227CALIBRATOR STANDARD KIT FOR ASTRA SYSTEMK884225TOTAL PROTEIN REAGENT KIT FOR ASTRA SYSTEMSK884226AMYLASE REAGENT KIT FOR ASTRA SYSTEMSK882587A-KEM ALBUMIN REAGENT KIT FOR ASTRA SYSTEMK882586A-KEM CALCIUM REAGENT KIT FOR ASTRA SYSTEM

View all 13 devices →

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

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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