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FDA 510(k)

RAICHEM(TM) UREA NITROGEN (COLOR) REAGENT

K-Number: K896845 · 1990-02-16

ApplicantReagents Applications, Inc.
Decision Date1990-02-16
Product CodeCDL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RAICHEM(TM) UREA NITROGEN (COLOR) REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Reagents Applications, Inc.. It received FDA 510(k) clearance on 1990-02-16 under 510(k) number K896845. The device is classified under product code CDL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RAICHEM(TM) UREA NITROGEN (COLOR) REAGENT?

RAICHEM(TM) UREA NITROGEN (COLOR) REAGENT is a medical device that received FDA 510(k) clearance on 1990-02-16. The listed applicant is Reagents Applications, Inc.. The 510(k) number is K896845.

When did RAICHEM(TM) UREA NITROGEN (COLOR) REAGENT receive FDA 510(k) clearance?

RAICHEM(TM) UREA NITROGEN (COLOR) REAGENT received FDA 510(k) clearance on 1990-02-16, under 510(k) number K896845.

Who is the listed applicant for RAICHEM(TM) UREA NITROGEN (COLOR) REAGENT?

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

What is the FDA product code for RAICHEM(TM) UREA NITROGEN (COLOR) REAGENT?

The FDA product code for RAICHEM(TM) UREA NITROGEN (COLOR) REAGENT is CDL.

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Other records listing Reagents Applications, Inc. as applicant

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K982056RAICHEM CO2 REAGENTK972853CHOLESTEROL RAPID LIQUID REAGENTK922904RAI-TROL FRUCTOSAMINE SERUM CONTROLS I AND IIK915191RAI-TROL ELEVATED LIPIDS CONTROLK913398RAICHEM(TM) CREATINE KINASE-MB REAGENTK911900RAICHEM SPIA C3 REAGENT

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Related Devices (Code: CDL)

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.

K893128STANBIO ENZYMATIC UREA NITROGEN DETERMINAT #2010Stanbio LaboratoryK871651COLORIMETRIC BUN REAGENT KITBiochemical Trade, Inc.K864742UREA NITROGEN(BUN), COLORIMETRIC METHODTech-Co, Inc.K863889UREA NITROGEN TESTU. S. Diagnostics, Inc.K863076UREAFASTJ. D. Assoc.K860154BUN (ENZYMATIC BERTHELOT) REAGENT SETSterling 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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