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FDA 510(k)

CPK REAGENT SET, NAD REDUCTION

K-Number: K781719 · 1978-11-03

ApplicantMedical Analysis Systems, Inc.
Decision Date1978-11-03
Product CodeCGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CPK REAGENT SET, NAD REDUCTION 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 1978-11-03 under 510(k) number K781719. 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 CPK REAGENT SET, NAD REDUCTION?

CPK REAGENT SET, NAD REDUCTION is a medical device that received FDA 510(k) clearance on 1978-11-03. The listed applicant is Medical Analysis Systems, Inc.. The 510(k) number is K781719.

When did CPK REAGENT SET, NAD REDUCTION receive FDA 510(k) clearance?

CPK REAGENT SET, NAD REDUCTION received FDA 510(k) clearance on 1978-11-03, under 510(k) number K781719.

Who is the listed applicant for CPK REAGENT SET, NAD REDUCTION?

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 CPK REAGENT SET, NAD REDUCTION?

The FDA product code for CPK REAGENT SET, NAD REDUCTION is CGS.

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Related Devices (Code: CGS)

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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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