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)

GENCHEM CO2 ACID REAGENT

K-Number: K040975 · 2004-12-27

ApplicantGenchem, Inc.
Decision Date2004-12-27
Product CodeJFL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GENCHEM CO2 ACID REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Genchem, Inc.. It received FDA 510(k) clearance on 2004-12-27 under 510(k) number K040975. The device is classified under product code JFL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GENCHEM CO2 ACID REAGENT?

GENCHEM CO2 ACID REAGENT is a medical device that received FDA 510(k) clearance on 2004-12-27. The listed applicant is Genchem, Inc.. The 510(k) number is K040975.

When did GENCHEM CO2 ACID REAGENT receive FDA 510(k) clearance?

GENCHEM CO2 ACID REAGENT received FDA 510(k) clearance on 2004-12-27, under 510(k) number K040975.

Who is the listed applicant for GENCHEM CO2 ACID REAGENT?

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

What is the FDA product code for GENCHEM CO2 ACID REAGENT?

The FDA product code for GENCHEM CO2 ACID REAGENT is JFL.

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 Genchem, 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.

K090283CALIBRATOR 1,2, AND 3 MODELS: GEN-CAL1, GEN-CAL2, AND GEN-CAL3K040972CALCIUM, AZO DYE REAGENTK040973BUN REAGENTK040977GENCHEM ELECTROLYTE BUFFERK040974GLUCOSE OXIDASE, GLUCOSEK040976GENCHEM CREATININE REAGENT

View all 8 devices →

Related Devices (Code: JFL)

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.

K191298i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K014034MODIFICATION TO SYNCHRON LX CLINICAL CHEMISTRY SYSTEMS (LX20 AND LX20 PRO)Beckman Coulter, Inc.K963541SIGMA DIAGNOSTICS CO2 ACID REAGENTSigma Diagnostics, Inc.K963538SIGMA DIAGNOSTICS CO2ALKALINE BUFFERSigma Diagnostics, Inc.K963540SIGMA DIAGNOSTICS ELECTROLYTE BUFFERSigma Diagnostics, Inc.K963005NOVA 16 ANALYZER (MODIFICATION POINT OF CARE USAGE)Nova Biomedical Corp.

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.

↑