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FDA 510(k)

PARAMAX CREATINE KINASE REAGENT

K-Number: K831537 · 1983-06-22

ApplicantAmerican Dade
Decision Date1983-06-22
Product CodeCGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PARAMAX CREATINE KINASE REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is American Dade. It received FDA 510(k) clearance on 1983-06-22 under 510(k) number K831537. The device is classified under product code CGS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PARAMAX CREATINE KINASE REAGENT?

PARAMAX CREATINE KINASE REAGENT is a medical device that received FDA 510(k) clearance on 1983-06-22. The listed applicant is American Dade. The 510(k) number is K831537.

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

PARAMAX CREATINE KINASE REAGENT received FDA 510(k) clearance on 1983-06-22, under 510(k) number K831537.

Who is the listed applicant for PARAMAX CREATINE KINASE REAGENT?

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

What is the FDA product code for PARAMAX CREATINE KINASE REAGENT?

The FDA product code for PARAMAX CREATINE KINASE REAGENT is CGS.

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Other records listing American Dade 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.

K873051STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAYK873171STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAYK873052STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAYK872789PARAMAX URINE/CSF CALIBRATORK872195DATA-FI DIMERTEST LATEX ASSAYK872196AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III

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Related Devices (Code: CGS)

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.

K191296Pointe Scientific Creatinine Kinase (CK) Reagent SetMedtest DXK182702SEKURE Creatine Kinase AssaySekisui Diagnostics P.E.I., Inc.K160724ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 CalibratorSiemens Healthcare Diagnostics, Inc.K123977RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATORRandox Laboratories, Ltd.K112416CPK REAGENTVital Diagnostics (Manufacturing) PtyltdK083465DIMENSION VISTA CREATINE KINASE FLEX REAGENT CARTRIDGE AND DIMENSION VISTA CREATINE KINASE MB FLEX REAGENT CARTRIDGESiemens Healthcare Diagnostics

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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