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FDA 510(k)

TANDEM - E-CKMB IMMUNOENZYMETRIC ASSAY

K-Number: K832139 · 1983-08-12

ApplicantHybritech, Inc.
Decision Date1983-08-12
Product CodeJHY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TANDEM - E-CKMB IMMUNOENZYMETRIC ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Hybritech, Inc.. It received FDA 510(k) clearance on 1983-08-12 under 510(k) number K832139. The device is classified under product code JHY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TANDEM - E-CKMB IMMUNOENZYMETRIC ASSAY?

TANDEM - E-CKMB IMMUNOENZYMETRIC ASSAY is a medical device that received FDA 510(k) clearance on 1983-08-12. The listed applicant is Hybritech, Inc.. The 510(k) number is K832139.

When did TANDEM - E-CKMB IMMUNOENZYMETRIC ASSAY receive FDA 510(k) clearance?

TANDEM - E-CKMB IMMUNOENZYMETRIC ASSAY received FDA 510(k) clearance on 1983-08-12, under 510(k) number K832139.

Who is the listed applicant for TANDEM - E-CKMB IMMUNOENZYMETRIC ASSAY?

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

What is the FDA product code for TANDEM - E-CKMB IMMUNOENZYMETRIC ASSAY?

The FDA product code for TANDEM - E-CKMB IMMUNOENZYMETRIC ASSAY is JHY.

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Other records listing Hybritech, 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.

K972666TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAYK961573TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAYK930810TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAYK922754TANDEM-E IGE II CALIBRATION VERIFICATION SETK921745HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNOK921252TANDEM-E FERRITIN CALIBRATION VERIFICATION CONROL

View all 63 devices →

Related Devices (Code: JHY)

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.

K132571ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAYRoche DiagnosticsK070835OLYMPUS CK-MB REAGENTOlympus Life & Material Science Europa GmbH (IrishK022757SPIFE CK KIT, MODEL 3332, 3333Helena LaboratoriesK022654MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MBRoche Diagnostics Corp.K974421ELECSYS CK-MB STATBoehringer Mannheim Corp.K970343MMB METHODDade Chemistry Systems, 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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