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)

ENZYMATIC UREA NITROGEN REAGENT SET REVI

K-Number: K800719 · 1980-05-08

ApplicantMacomb Chemical Co.
Decision Date1980-05-08
Product CodeCDQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ENZYMATIC UREA NITROGEN REAGENT SET REVI is the device name listed in this FDA 510(k) record. The listed applicant is Macomb Chemical Co.. It received FDA 510(k) clearance on 1980-05-08 under 510(k) number K800719. The device is classified under product code CDQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENZYMATIC UREA NITROGEN REAGENT SET REVI?

ENZYMATIC UREA NITROGEN REAGENT SET REVI is a medical device that received FDA 510(k) clearance on 1980-05-08. The listed applicant is Macomb Chemical Co.. The 510(k) number is K800719.

When did ENZYMATIC UREA NITROGEN REAGENT SET REVI receive FDA 510(k) clearance?

ENZYMATIC UREA NITROGEN REAGENT SET REVI received FDA 510(k) clearance on 1980-05-08, under 510(k) number K800719.

Who is the listed applicant for ENZYMATIC UREA NITROGEN REAGENT SET REVI?

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

What is the FDA product code for ENZYMATIC UREA NITROGEN REAGENT SET REVI?

The FDA product code for ENZYMATIC UREA NITROGEN REAGENT SET REVI is CDQ.

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 Macomb Chemical 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.

K830095RAPID CHEM ANALYZER IIK823720SPECTROPHOTOMETERK810958GLYCOHEMOGLOBINK801086P-NITROPHENYL PHOSPHATEK800720MACOMB NAD-NICOTINAMIDE ADENINE DINUCLEOK792533CREATINE PHOSPHOKINASE (CPK) REAGENT SET

View all 23 devices →

Related Devices (Code: CDQ)

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.

K203771Urea Nitrogen2Abbott Ireland Diagnostics DivisionK110675EASYRA UREA NITROGEN AND CREATININE REAGENTSMedica Corp.K073295UREA/BUN, SCAL, NORTROL, ABTROLThermofisher Scientific OYK070146ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CPHoriba AbxK060120TECO CX3 REAGENT SET FOR SYNCHRON CX SYSTEMTeco DiagnosticsK041051RAICHEM BUN RATE REAGENT (LIQUID)Hemagen 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.

↑