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FDA 510(k)

AMRESCO UREA NITROGEN (BUN) REAGENTS, PROD # 7123

K-Number: K891912 · 1989-06-19

ApplicantAmerican Research Products Co.
Decision Date1989-06-19
Product CodeCDQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AMRESCO UREA NITROGEN (BUN) REAGENTS, PROD # 7123 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 1989-06-19 under 510(k) number K891912. 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 AMRESCO UREA NITROGEN (BUN) REAGENTS, PROD # 7123?

AMRESCO UREA NITROGEN (BUN) REAGENTS, PROD # 7123 is a medical device that received FDA 510(k) clearance on 1989-06-19. The listed applicant is American Research Products Co.. The 510(k) number is K891912.

When did AMRESCO UREA NITROGEN (BUN) REAGENTS, PROD # 7123 receive FDA 510(k) clearance?

AMRESCO UREA NITROGEN (BUN) REAGENTS, PROD # 7123 received FDA 510(k) clearance on 1989-06-19, under 510(k) number K891912.

Who is the listed applicant for AMRESCO UREA NITROGEN (BUN) REAGENTS, PROD # 7123?

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 AMRESCO UREA NITROGEN (BUN) REAGENTS, PROD # 7123?

The FDA product code for AMRESCO UREA NITROGEN (BUN) REAGENTS, PROD # 7123 is CDQ.

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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

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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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