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FDA 510(k)

TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY

K-Number: K884085 · 1988-12-02

ApplicantHybritech, Inc.
Decision Date1988-12-02
Product CodeJHY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TANDEM ICON QSR 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 1988-12-02 under 510(k) number K884085. 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 ICON QSR CKMB IMMUNOENZYMETRIC ASSAY?

TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY is a medical device that received FDA 510(k) clearance on 1988-12-02. The listed applicant is Hybritech, Inc.. The 510(k) number is K884085.

When did TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY receive FDA 510(k) clearance?

TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY received FDA 510(k) clearance on 1988-12-02, under 510(k) number K884085.

Who is the listed applicant for TANDEM ICON QSR 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 ICON QSR CKMB IMMUNOENZYMETRIC ASSAY?

The FDA product code for TANDEM ICON QSR 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 IMMUNOK920556TANDEM-E HCG CALIBRATION VERIFICATION CONTROL SET

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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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