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FDA 510(k)

UREA NITROGEN (GLDH) REAGENT SET (UV)

K-Number: K862210 · 1986-07-01

ApplicantSterling Diagnostics, Inc.
Decision Date1986-07-01
Product CodeCDQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

UREA NITROGEN (GLDH) REAGENT SET (UV) is the device name listed in this FDA 510(k) record. The listed applicant is Sterling Diagnostics, Inc.. It received FDA 510(k) clearance on 1986-07-01 under 510(k) number K862210. 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 UREA NITROGEN (GLDH) REAGENT SET (UV)?

UREA NITROGEN (GLDH) REAGENT SET (UV) is a medical device that received FDA 510(k) clearance on 1986-07-01. The listed applicant is Sterling Diagnostics, Inc.. The 510(k) number is K862210.

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

UREA NITROGEN (GLDH) REAGENT SET (UV) received FDA 510(k) clearance on 1986-07-01, under 510(k) number K862210.

Who is the listed applicant for UREA NITROGEN (GLDH) REAGENT SET (UV)?

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

What is the FDA product code for UREA NITROGEN (GLDH) REAGENT SET (UV)?

The FDA product code for UREA NITROGEN (GLDH) REAGENT SET (UV) is CDQ.

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Other records listing Sterling Diagnostics, Inc. 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.

K921412MICROPROTEIN REAGENT SETK914609TRIGLYCERIDES REAGENT SETK914039SODIUM REAGENT SETK914040PHOSPHOLIPID REAGENT SETK862255LACTATE DEHYDROGENASE (LDH) REAGENT SET (UV RATE)K861962VANILMANDELIC ACID (VMA) 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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