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FDA 510(k)

AMRESCO FLOW PAC UREA NITROGEN REAGENTS #1346

K-Number: K863425 · 1986-10-01

ApplicantAmerican Research Products Co.
Decision Date1986-10-01
Product CodeCDW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AMRESCO FLOW PAC UREA NITROGEN REAGENTS #1346 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 1986-10-01 under 510(k) number K863425. 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 AMRESCO FLOW PAC UREA NITROGEN REAGENTS #1346?

AMRESCO FLOW PAC UREA NITROGEN REAGENTS #1346 is a medical device that received FDA 510(k) clearance on 1986-10-01. The listed applicant is American Research Products Co.. The 510(k) number is K863425.

When did AMRESCO FLOW PAC UREA NITROGEN REAGENTS #1346 receive FDA 510(k) clearance?

AMRESCO FLOW PAC UREA NITROGEN REAGENTS #1346 received FDA 510(k) clearance on 1986-10-01, under 510(k) number K863425.

Who is the listed applicant for AMRESCO FLOW PAC UREA NITROGEN REAGENTS #1346?

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 FLOW PAC UREA NITROGEN REAGENTS #1346?

The FDA product code for AMRESCO FLOW PAC UREA NITROGEN REAGENTS #1346 is CDW.

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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 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

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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.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.

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