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FDA 510(k)

COULTER DART CK-MB ISOENZYME REAGENT SYSTEM

K-Number: K872041 · 1987-09-16

ApplicantCoulter Electronics, Inc.
Decision Date1987-09-16
Product CodeJHT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COULTER DART CK-MB ISOENZYME REAGENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Coulter Electronics, Inc.. It received FDA 510(k) clearance on 1987-09-16 under 510(k) number K872041. The device is classified under product code JHT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COULTER DART CK-MB ISOENZYME REAGENT SYSTEM?

COULTER DART CK-MB ISOENZYME REAGENT SYSTEM is a medical device that received FDA 510(k) clearance on 1987-09-16. The listed applicant is Coulter Electronics, Inc.. The 510(k) number is K872041.

When did COULTER DART CK-MB ISOENZYME REAGENT SYSTEM receive FDA 510(k) clearance?

COULTER DART CK-MB ISOENZYME REAGENT SYSTEM received FDA 510(k) clearance on 1987-09-16, under 510(k) number K872041.

Who is the listed applicant for COULTER DART CK-MB ISOENZYME REAGENT SYSTEM?

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

What is the FDA product code for COULTER DART CK-MB ISOENZYME REAGENT SYSTEM?

The FDA product code for COULTER DART CK-MB ISOENZYME REAGENT SYSTEM is JHT.

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Other records listing Coulter Electronics, 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.

K923951CD8 CYTOSPHERES KITK930119COULTER RETIC-C CELL CONTROLK921279CD4 CYTOSPHERES KITK923530COULTER MULTI-Q-PREPK922181COULTER MH009K922704COULTER MAXM W/ AUTOLOADER

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Related Devices (Code: JHT)

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.

K022409SPECTRAL'S CARDIAC STATUS CK-MB RAPID TESTSpectral Diagnostics, Inc.K991299MODIFICATION TO CARDIAC STATUS CK-MB/MYOGLOBIN RAPID ONE-STEP TEST, LIFESIGN MI CK-MB/MYOGLOBIN, LIFESIGN CK-MB/MYOGLOBIPrinceton BioMeditech Corp.K930359CARDIO REP-CAT. NO. 1400 & CK ISOFORMS KIT 3305Helena LaboratoriesK904721DSL CK-MB (DSL #3200)Diagnostic Systems Laboratories, Inc.K904866COULTER CK-MB ISOENZYME REAGENTCoulter Electronics, Inc.K901450MODIFIED LABEL FOR EMBRIA-CK, QUICK-MB/MICROMI-MBIntl. Immunoassay Laboratories, Inc.

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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