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FDA 510(k)

CREATINE LIQUID STABLE REAGENT SET

K-Number: K851849 · 1985-05-20

ApplicantMedical Analysis Systems, Inc.
Decision Date1985-05-20
Product CodeCGX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CREATINE LIQUID STABLE REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Medical Analysis Systems, Inc.. It received FDA 510(k) clearance on 1985-05-20 under 510(k) number K851849. 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 CREATINE LIQUID STABLE REAGENT SET?

CREATINE LIQUID STABLE REAGENT SET is a medical device that received FDA 510(k) clearance on 1985-05-20. The listed applicant is Medical Analysis Systems, Inc.. The 510(k) number is K851849.

When did CREATINE LIQUID STABLE REAGENT SET receive FDA 510(k) clearance?

CREATINE LIQUID STABLE REAGENT SET received FDA 510(k) clearance on 1985-05-20, under 510(k) number K851849.

Who is the listed applicant for CREATINE LIQUID STABLE REAGENT SET?

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

What is the FDA product code for CREATINE LIQUID STABLE REAGENT SET?

The FDA product code for CREATINE LIQUID STABLE REAGENT SET is CGX.

Related Clinical Trials

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Other records listing Medical Analysis Systems, 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.

K042717MAS, DADE AND LIQUID ASSAYED DIABETES CONTROLK041194ABBOTT ARCHITECT STAT TROPONIN I LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL L, M AND HK040880MAS CARDIOIMMUNE TL LIQUID ASSAYED CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3K032826MAS PAR TDMK032335MAS CARDIOIMMUNE PROBNP, MAS CARDIOIMMUNE TLK031890MAS BILIRUBIN LIQUID ASSAYED BILIRUBIN CONTROL

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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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