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FDA 510(k)

TANDEM ICON LH ASSAY (URINE) IMMUNOENZYMETRIC KIT

K-Number: K860984 · 1986-04-29

ApplicantHybritech, Inc.
Decision Date1986-04-29
Product CodeCEP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TANDEM ICON LH ASSAY (URINE) IMMUNOENZYMETRIC KIT is the device name listed in this FDA 510(k) record. The listed applicant is Hybritech, Inc.. It received FDA 510(k) clearance on 1986-04-29 under 510(k) number K860984. The device is classified under product code CEP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TANDEM ICON LH ASSAY (URINE) IMMUNOENZYMETRIC KIT?

TANDEM ICON LH ASSAY (URINE) IMMUNOENZYMETRIC KIT is a medical device that received FDA 510(k) clearance on 1986-04-29. The listed applicant is Hybritech, Inc.. The 510(k) number is K860984.

When did TANDEM ICON LH ASSAY (URINE) IMMUNOENZYMETRIC KIT receive FDA 510(k) clearance?

TANDEM ICON LH ASSAY (URINE) IMMUNOENZYMETRIC KIT received FDA 510(k) clearance on 1986-04-29, under 510(k) number K860984.

Who is the listed applicant for TANDEM ICON LH ASSAY (URINE) IMMUNOENZYMETRIC KIT?

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 LH ASSAY (URINE) IMMUNOENZYMETRIC KIT?

The FDA product code for TANDEM ICON LH ASSAY (URINE) IMMUNOENZYMETRIC KIT is CEP.

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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: CEP)

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.

K013582MAYBE?MOM MINI OVULATION MICROSCOPEMaybe?MomK022829INSTANT-VIEW LH OVULATION PREDICTING TESTAlfa Scientific Designs, Inc.K021409AT HOME OVULATION TEST, MODEL 9032Phamatech, Inc.K013874CLEARPLANE EASY OVULATION TESTUnipath , Ltd.K013323TCI-31 LIFELONG OVULATION TESTERTci New YorkK012252QUIK-CHECK OVULATION PREDICTORACON 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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