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FDA 510(k)

ENZYMATIC UREA NITROGEN REAGENT SET

K-Number: K892331 · 1989-06-20

ApplicantAmerican Monitor Corp.
Decision Date1989-06-20
Product CodeCDQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ENZYMATIC UREA NITROGEN REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is American Monitor Corp.. It received FDA 510(k) clearance on 1989-06-20 under 510(k) number K892331. 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?

ENZYMATIC UREA NITROGEN REAGENT SET is a medical device that received FDA 510(k) clearance on 1989-06-20. The listed applicant is American Monitor Corp.. The 510(k) number is K892331.

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

ENZYMATIC UREA NITROGEN REAGENT SET received FDA 510(k) clearance on 1989-06-20, under 510(k) number K892331.

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

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

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

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

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Other records listing American Monitor Corp. 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.

K896000ASPARTATE AMINOTRANFERASE (AST)K895999PHOSPHORUSK896001ALANINE AMINOTRANSFERASE (ALT)K895423ACCESS CHEMISTRY ANALYZERK893137EXCEL (TM) CHEMISTRY ANALYZERK893479CHOLESTEROL REAGENT SET

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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.

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