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FDA 510(k)

PARAMAX CREATININE REAGENT

K-Number: K873531 · 1987-11-23

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

Device Summary

PARAMAX CREATININE 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 K873531. The device is classified under product code CGX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PARAMAX CREATININE REAGENT?

PARAMAX CREATININE 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 K873531.

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

PARAMAX CREATININE REAGENT received FDA 510(k) clearance on 1987-11-23, under 510(k) number K873531.

Who is the listed applicant for PARAMAX CREATININE 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 CREATININE REAGENT?

The FDA product code for PARAMAX CREATININE REAGENT is CGX.

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Related Devices (Code: CGX)

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.

K252206Nova Allegro UACR Assay, Nova Allegro AnalyzerNova Biomedical CorporationK251058Tru Kidney Health Test Panel; Tru AnalyzerTruvian HealthK242685Atellica® CH Creatinine_3 (Crea3)Siemens Healthcare Diagnostics, Inc.K221813Nova Allegro UACR Assay, Nova Allegro AnalyzerNova Biomedical CorporationK210452Creatinine2Abbott Ireland Diagnostics DivisionK161494Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)Siemens Healthcare 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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