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FDA 510(k)

CREATINE KINASE TEST (CK) ITEM NUMBER 65411

K-Number: K903333 · 1990-08-17

ApplicantEm Diagnostic Systems, Inc.
Decision Date1990-08-17
Product CodeCGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CREATINE KINASE TEST (CK) ITEM NUMBER 65411 is the device name listed in this FDA 510(k) record. The listed applicant is Em Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1990-08-17 under 510(k) number K903333. 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 TEST (CK) ITEM NUMBER 65411?

CREATINE KINASE TEST (CK) ITEM NUMBER 65411 is a medical device that received FDA 510(k) clearance on 1990-08-17. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K903333.

When did CREATINE KINASE TEST (CK) ITEM NUMBER 65411 receive FDA 510(k) clearance?

CREATINE KINASE TEST (CK) ITEM NUMBER 65411 received FDA 510(k) clearance on 1990-08-17, under 510(k) number K903333.

Who is the listed applicant for CREATINE KINASE TEST (CK) ITEM NUMBER 65411?

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

What is the FDA product code for CREATINE KINASE TEST (CK) ITEM NUMBER 65411?

The FDA product code for CREATINE KINASE TEST (CK) ITEM NUMBER 65411 is CGS.

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Other records listing Em Diagnostic Systems, 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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