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FDA 510(k)

SYNERMED UREA NITROGEN REAGENT KIT

K-Number: K911248 · 1991-06-03

ApplicantSynermed, Inc.
Decision Date1991-06-03
Product CodeCDQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SYNERMED UREA NITROGEN REAGENT KIT is the device name listed in this FDA 510(k) record. The listed applicant is Synermed, Inc.. It received FDA 510(k) clearance on 1991-06-03 under 510(k) number K911248. 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 SYNERMED UREA NITROGEN REAGENT KIT?

SYNERMED UREA NITROGEN REAGENT KIT is a medical device that received FDA 510(k) clearance on 1991-06-03. The listed applicant is Synermed, Inc.. The 510(k) number is K911248.

When did SYNERMED UREA NITROGEN REAGENT KIT receive FDA 510(k) clearance?

SYNERMED UREA NITROGEN REAGENT KIT received FDA 510(k) clearance on 1991-06-03, under 510(k) number K911248.

Who is the listed applicant for SYNERMED UREA NITROGEN REAGENT KIT?

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

What is the FDA product code for SYNERMED UREA NITROGEN REAGENT KIT?

The FDA product code for SYNERMED UREA NITROGEN REAGENT KIT is CDQ.

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Other records listing Synermed, 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.

K973109SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KITK972716SYNERMED TOTAL BILIRUBIN REAGENT KITK971491SYNERMED IR 200 CHEMISTRY ANALYZERK962479SYNERMED ISE REAGENTSK963939SYNERMED DIRECT BILIRUBIN REAGENT KITK960793SYNERMED ENZYMATIC CO2 REAGENT KIT

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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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