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)

FLOW-PAC UREA NITROGEN REAGENT SET 2214, 2814

K-Number: K871320 · 1987-04-22

ApplicantAmerican Research Products Co.
Decision Date1987-04-22
Product CodeCDW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FLOW-PAC UREA NITROGEN REAGENT SET 2214, 2814 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 1987-04-22 under 510(k) number K871320. The device is classified under product code CDW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLOW-PAC UREA NITROGEN REAGENT SET 2214, 2814?

FLOW-PAC UREA NITROGEN REAGENT SET 2214, 2814 is a medical device that received FDA 510(k) clearance on 1987-04-22. The listed applicant is American Research Products Co.. The 510(k) number is K871320.

When did FLOW-PAC UREA NITROGEN REAGENT SET 2214, 2814 receive FDA 510(k) clearance?

FLOW-PAC UREA NITROGEN REAGENT SET 2214, 2814 received FDA 510(k) clearance on 1987-04-22, under 510(k) number K871320.

Who is the listed applicant for FLOW-PAC UREA NITROGEN REAGENT SET 2214, 2814?

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 FLOW-PAC UREA NITROGEN REAGENT SET 2214, 2814?

The FDA product code for FLOW-PAC UREA NITROGEN REAGENT SET 2214, 2814 is CDW.

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 PROTEINK901964PHOSPHORUS REAGENTS PROD CODES 7763/7764/7563/7463K901960IRON REAGENTS PRODUCT CODES 7725 AND 7726K900827COLORIMETRIC CHLORIDE PRODUCT #4314125K901702NAD REDUCTION, ALT/SPGT CODES 7722,7723,7422,7522

View all 56 devices →

Related Devices (Code: CDW)

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.

K874532BLOOD UREA NITROGENCatachem, Inc.K863425AMRESCO FLOW PAC UREA NITROGEN REAGENTS #1346American Research Products Co.K861775TWIN BUN/GLUCOSEBoehringer Mannheim Corp.K860419UREA NITROGEN REAGENT SETSterling Diagnostics, Inc.K850937UREADilab, Inc.K844156UREA NITROGEN REAGENT SETLivonia Diagnostics, Inc.

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.

↑