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FDA 510(k)

PARAMAX UREA NITROGEN REAGENT

K-Number: K873532 · 1987-11-23

ApplicantBaxter Healthcare Corp
Decision Date1987-11-23
Product CodeCDQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PARAMAX UREA NITROGEN REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1987-11-23 under 510(k) number K873532. 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 PARAMAX UREA NITROGEN REAGENT?

PARAMAX UREA NITROGEN REAGENT is a medical device that received FDA 510(k) clearance on 1987-11-23. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K873532.

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

PARAMAX UREA NITROGEN REAGENT received FDA 510(k) clearance on 1987-11-23, under 510(k) number K873532.

Who is the listed applicant for PARAMAX UREA NITROGEN REAGENT?

The FDA 510(k) record lists Baxter Healthcare Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PARAMAX UREA NITROGEN REAGENT?

The FDA product code for PARAMAX UREA NITROGEN REAGENT is CDQ.

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Other records listing Baxter Healthcare Corp as applicant

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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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