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FDA 510(k)

TANDEM-M IMMUNOENZYMETRIC ASSAY FOR PROLACTIN

K-Number: K863860 · 1986-11-21

ApplicantHybritech, Inc.
Decision Date1986-11-21
Product CodeCFT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TANDEM-M IMMUNOENZYMETRIC ASSAY FOR PROLACTIN is the device name listed in this FDA 510(k) record. The listed applicant is Hybritech, Inc.. It received FDA 510(k) clearance on 1986-11-21 under 510(k) number K863860. The device is classified under product code CFT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TANDEM-M IMMUNOENZYMETRIC ASSAY FOR PROLACTIN?

TANDEM-M IMMUNOENZYMETRIC ASSAY FOR PROLACTIN is a medical device that received FDA 510(k) clearance on 1986-11-21. The listed applicant is Hybritech, Inc.. The 510(k) number is K863860.

When did TANDEM-M IMMUNOENZYMETRIC ASSAY FOR PROLACTIN receive FDA 510(k) clearance?

TANDEM-M IMMUNOENZYMETRIC ASSAY FOR PROLACTIN received FDA 510(k) clearance on 1986-11-21, under 510(k) number K863860.

Who is the listed applicant for TANDEM-M IMMUNOENZYMETRIC ASSAY FOR PROLACTIN?

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-M IMMUNOENZYMETRIC ASSAY FOR PROLACTIN?

The FDA product code for TANDEM-M IMMUNOENZYMETRIC ASSAY FOR PROLACTIN is CFT.

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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

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Related Devices (Code: CFT)

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.

K971921PROLACTIN (PRL) HORMONE MICROPLATE ELISAMonobindK970281VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALIBRATORSJohnson & Johnson Clinical Diagnostics, Inc.K970188SEALITE SCIENCES, INC. AQUALITE PROLACTINSealite Sciences, Inc.K964748ELECSYS PROLACTIN ASSAYBoehringer Mannheim Corp.K960561DSL ACTIVE PROLACTIN ELISA MODEL 10-4500Diagnostic Systems Laboratories, Inc.K960060DSL ACTIVE PROLACTIN IRMADiagnostic Systems 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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