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FDA 510(k)

EMDS CREATINE KINASE ISOENZYME CKMB TEST PACK

K-Number: K861061 · 1986-04-24

ApplicantEm Diagnostic Systems, Inc.
Decision Date1986-04-24
Product CodeCGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EMDS CREATINE KINASE ISOENZYME CKMB TEST PACK 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 1986-04-24 under 510(k) number K861061. 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 EMDS CREATINE KINASE ISOENZYME CKMB TEST PACK?

EMDS CREATINE KINASE ISOENZYME CKMB TEST PACK is a medical device that received FDA 510(k) clearance on 1986-04-24. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K861061.

When did EMDS CREATINE KINASE ISOENZYME CKMB TEST PACK receive FDA 510(k) clearance?

EMDS CREATINE KINASE ISOENZYME CKMB TEST PACK received FDA 510(k) clearance on 1986-04-24, under 510(k) number K861061.

Who is the listed applicant for EMDS CREATINE KINASE ISOENZYME CKMB TEST PACK?

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 EMDS CREATINE KINASE ISOENZYME CKMB TEST PACK?

The FDA product code for EMDS CREATINE KINASE ISOENZYME CKMB TEST PACK is CGS.

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Other records listing Em Diagnostic Systems, Inc. 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.

K935181ASPARTATE AMINOTRANSFERASE (AST) TESTK935180ALANINE AMINOTRANSFERASE (ALT) TESTK935178EMDS PHOSPHOROUS (PHOS) TESTK935179EMDS ALBUMIN (ALB) TESTK935175LACTATE DEHYDROGENASE (LD)K935174TOTAL PROTEIN TEST (TPRO)

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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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