Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

POTASSIUM CHLORIDE SOLUTION -2 MOLAR

K-Number: K841417 · 1984-05-16

ApplicantReagent Laboratory, Inc.
Decision Date1984-05-16
Product CodeJGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

POTASSIUM CHLORIDE SOLUTION -2 MOLAR is the device name listed in this FDA 510(k) record. The listed applicant is Reagent Laboratory, Inc.. It received FDA 510(k) clearance on 1984-05-16 under 510(k) number K841417. The device is classified under product code JGS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POTASSIUM CHLORIDE SOLUTION -2 MOLAR?

POTASSIUM CHLORIDE SOLUTION -2 MOLAR is a medical device that received FDA 510(k) clearance on 1984-05-16. The listed applicant is Reagent Laboratory, Inc.. The 510(k) number is K841417.

When did POTASSIUM CHLORIDE SOLUTION -2 MOLAR receive FDA 510(k) clearance?

POTASSIUM CHLORIDE SOLUTION -2 MOLAR received FDA 510(k) clearance on 1984-05-16, under 510(k) number K841417.

Who is the listed applicant for POTASSIUM CHLORIDE SOLUTION -2 MOLAR?

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

What is the FDA product code for POTASSIUM CHLORIDE SOLUTION -2 MOLAR?

The FDA product code for POTASSIUM CHLORIDE SOLUTION -2 MOLAR is JGS.

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 Reagent Laboratory, 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.

K863502SOLUTION B- NA 50MEQ/L, K 40 MEQ/LK863503HEMOLYSEK863550POTASSIUM HYDROXIDE 10% W/VK860143URINE DILUENT-FOR USE WITH ION SELECTIVE ELECTRODEK842982FORMALIN BUFFEREDK842785STAIN, METHYLENE BLUE-EOSIN

View all 19 devices →

Related Devices (Code: JGS)

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.

K252475ABL90 FLEX PLUS SystemRadiometer Medicals ApsK230275i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K222438A-LYTE® Integrated Multisensor (IMT Na K Cl)Siemens Healthcare Diagnostics, Inc.K220977ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry AnalyzerBeckman Coulter Laboratory Systems (Suzhou) Co., Ltd.K213486GLP systems TrackAbbott LaboratoriesK200403Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation

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.

↑