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)

TOTAL CO2 REAGENT SET

K-Number: K832071 · 1983-08-11

ApplicantAmerican Research Products Co.
Decision Date1983-08-11
Product CodeCIE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TOTAL CO2 REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is American Research Products Co.. It received FDA 510(k) clearance on 1983-08-11 under 510(k) number K832071. The device is classified under product code CIE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOTAL CO2 REAGENT SET?

TOTAL CO2 REAGENT SET is a medical device that received FDA 510(k) clearance on 1983-08-11. The listed applicant is American Research Products Co.. The 510(k) number is K832071.

When did TOTAL CO2 REAGENT SET receive FDA 510(k) clearance?

TOTAL CO2 REAGENT SET received FDA 510(k) clearance on 1983-08-11, under 510(k) number K832071.

Who is the listed applicant for TOTAL CO2 REAGENT SET?

The FDA 510(k) record lists American Research Products Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TOTAL CO2 REAGENT SET?

The FDA product code for TOTAL CO2 REAGENT SET is CIE.

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 American Research Products Co. 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.

K942984BUN REAGENTK901527BIURET (COLORMETRIC), TOTAL PROTEINK901960IRON REAGENTS PRODUCT CODES 7725 AND 7726K901964PHOSPHORUS REAGENTS PROD CODES 7763/7764/7563/7463K900827COLORIMETRIC CHLORIDE PRODUCT #4314125K901702NAD REDUCTION, ALT/SPGT CODES 7722,7723,7422,7522

View all 56 devices →

Related Devices (Code: CIE)

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.

K904761P/N 35310, IL TEST ALKALINE PHOSPHATASE REAGENTInstrumentation Laboratory COK880967MICRO CO2 APPARATUSHf Scientific, Inc.K864313CO2 REAGENT SETHf Scientific, Inc.K820091AIRMED SMOKE EVACUATION & FILTERJames L. Geraci & Associates, Inc.K800524SERALYZER REFLECTANCE PHOTOMETER/CALIB.Miles Laboratories, Inc.K771610CARBON DIOXIDE ANALYZERCorning Medical & Scientific

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.

↑