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FDA 510(k)

CREATINKINETIC

K-Number: K863079 · 1986-12-12

ApplicantJ. D. Assoc.
Decision Date1986-12-12
Product CodeCGX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CREATINKINETIC is the device name listed in this FDA 510(k) record. The listed applicant is J. D. Assoc.. It received FDA 510(k) clearance on 1986-12-12 under 510(k) number K863079. 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 CREATINKINETIC?

CREATINKINETIC is a medical device that received FDA 510(k) clearance on 1986-12-12. The listed applicant is J. D. Assoc.. The 510(k) number is K863079.

When did CREATINKINETIC receive FDA 510(k) clearance?

CREATINKINETIC received FDA 510(k) clearance on 1986-12-12, under 510(k) number K863079.

Who is the listed applicant for CREATINKINETIC?

The FDA 510(k) record lists J. D. Assoc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CREATINKINETIC?

The FDA product code for CREATINKINETIC is CGX.

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Other records listing J. D. Assoc. 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.

K863103PEG 6,000K863054AST S.C.E. (GOT)K863069MAGNESIOMETERK863068LDH S.C.E.K863112PROTEINMETERK863053ALT S.C.E. (GPT)

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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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