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FDA 510(k)

CARDIOZYME PLUS CK-TOTAL ITEM #65046 (A)

K-Number: K811576 · 1981-06-25

ApplicantHarleco
Decision Date1981-06-25
Product CodeCGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CARDIOZYME PLUS CK-TOTAL ITEM #65046 (A) is the device name listed in this FDA 510(k) record. The listed applicant is Harleco. It received FDA 510(k) clearance on 1981-06-25 under 510(k) number K811576. 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 CARDIOZYME PLUS CK-TOTAL ITEM #65046 (A)?

CARDIOZYME PLUS CK-TOTAL ITEM #65046 (A) is a medical device that received FDA 510(k) clearance on 1981-06-25. The listed applicant is Harleco. The 510(k) number is K811576.

When did CARDIOZYME PLUS CK-TOTAL ITEM #65046 (A) receive FDA 510(k) clearance?

CARDIOZYME PLUS CK-TOTAL ITEM #65046 (A) received FDA 510(k) clearance on 1981-06-25, under 510(k) number K811576.

Who is the listed applicant for CARDIOZYME PLUS CK-TOTAL ITEM #65046 (A)?

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

What is the FDA product code for CARDIOZYME PLUS CK-TOTAL ITEM #65046 (A)?

The FDA product code for CARDIOZYME PLUS CK-TOTAL ITEM #65046 (A) is CGS.

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Other records listing Harleco 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.

K820233ULTRAZYME PLUS GAMMA GT(65055-65056)K813427ULTRACHEM GLUC-DHK813044ULTRACHEM ALB, ITEM #64970K813042ULTRACHEM GLUC-DH SET, ITEM #65048K813038ULTRACHEM TP, ITEM #64974K813041ULTRAZYME-GT, ITEM #64959 & 65032

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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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