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FDA 510(k)

CREATINE KINASE REAGENT CK LTS

K-Number: K831965 · 1983-09-12

ApplicantElectro-Nucleonics Laboratories, Inc.
Decision Date1983-09-12
Product CodeCGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CREATINE KINASE REAGENT CK LTS is the device name listed in this FDA 510(k) record. The listed applicant is Electro-Nucleonics Laboratories, Inc.. It received FDA 510(k) clearance on 1983-09-12 under 510(k) number K831965. 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 CREATINE KINASE REAGENT CK LTS?

CREATINE KINASE REAGENT CK LTS is a medical device that received FDA 510(k) clearance on 1983-09-12. The listed applicant is Electro-Nucleonics Laboratories, Inc.. The 510(k) number is K831965.

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

CREATINE KINASE REAGENT CK LTS received FDA 510(k) clearance on 1983-09-12, under 510(k) number K831965.

Who is the listed applicant for CREATINE KINASE REAGENT CK LTS?

The FDA 510(k) record lists Electro-Nucleonics Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CREATINE KINASE REAGENT CK LTS?

The FDA product code for CREATINE KINASE REAGENT CK LTS is CGS.

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Other records listing Electro-Nucleonics Laboratories, Inc. as applicant

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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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