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FDA 510(k)

CREA OR CREATININE

K-Number: K971908 · 1997-06-17

ApplicantCarolina Liquid Chemistries Corp.
Decision Date1997-06-17
Product CodeCGX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CREA OR CREATININE is the device name listed in this FDA 510(k) record. The listed applicant is Carolina Liquid Chemistries Corp.. It received FDA 510(k) clearance on 1997-06-17 under 510(k) number K971908. 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 CREA OR CREATININE?

CREA OR CREATININE is a medical device that received FDA 510(k) clearance on 1997-06-17. The listed applicant is Carolina Liquid Chemistries Corp.. The 510(k) number is K971908.

When did CREA OR CREATININE receive FDA 510(k) clearance?

CREA OR CREATININE received FDA 510(k) clearance on 1997-06-17, under 510(k) number K971908.

Who is the listed applicant for CREA OR CREATININE?

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

What is the FDA product code for CREA OR CREATININE?

The FDA product code for CREA OR CREATININE is CGX.

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Other records listing Carolina Liquid Chemistries Corp. 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.

K213211Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test SystemK972073TOTAL BILIRUBIN REAGENTK971907CALCIUM REAGENTK971324TRIGLYCERIDES, TG, OR TRIGK971967BUNK971467SYNCHRON CX SYSTEMS GLUCOSE REAGENT (GLU)

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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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