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)

REAGENT, BUN (UREA NITROGEN) DETERM.

K-Number: K760478 · 1976-10-29

ApplicantSimmler & Son, Inc.
Decision Date1976-10-29
Product CodeCDW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

REAGENT, BUN (UREA NITROGEN) DETERM. is the device name listed in this FDA 510(k) record. The listed applicant is Simmler & Son, Inc.. It received FDA 510(k) clearance on 1976-10-29 under 510(k) number K760478. 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 REAGENT, BUN (UREA NITROGEN) DETERM.?

REAGENT, BUN (UREA NITROGEN) DETERM. is a medical device that received FDA 510(k) clearance on 1976-10-29. The listed applicant is Simmler & Son, Inc.. The 510(k) number is K760478.

When did REAGENT, BUN (UREA NITROGEN) DETERM. receive FDA 510(k) clearance?

REAGENT, BUN (UREA NITROGEN) DETERM. received FDA 510(k) clearance on 1976-10-29, under 510(k) number K760478.

Who is the listed applicant for REAGENT, BUN (UREA NITROGEN) DETERM.?

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

What is the FDA product code for REAGENT, BUN (UREA NITROGEN) DETERM.?

The FDA product code for REAGENT, BUN (UREA NITROGEN) DETERM. 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 Simmler & Son, 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.

K780817GLOBIN-TERGEK771903LIPASEK771905GLYCEROL SUBSTRATEK771904GLYCEROL KINASEK771906PHOSPHATEK761086REAGENTS

View all 14 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.K871320FLOW-PAC UREA NITROGEN REAGENT SET 2214, 2814American Research Products Co.K863425AMRESCO FLOW PAC UREA NITROGEN REAGENTS #1346American Research Products Co.K861775TWIN BUN/GLUCOSEBoehringer Mannheim Corp.K860419UREA NITROGEN REAGENT SETSterling Diagnostics, Inc.K850937UREADilab, 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.

↑