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FDA 510(k)

TANDEMR M-PAK LH IMMUNOENZYMETRIC ASSAY

K-Number: K872131 · 1987-08-25

ApplicantHybritech, Inc.
Decision Date1987-08-25
Product CodeCEP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TANDEMR M-PAK LH 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 1987-08-25 under 510(k) number K872131. 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 TANDEMR M-PAK LH IMMUNOENZYMETRIC ASSAY?

TANDEMR M-PAK LH IMMUNOENZYMETRIC ASSAY is a medical device that received FDA 510(k) clearance on 1987-08-25. The listed applicant is Hybritech, Inc.. The 510(k) number is K872131.

When did TANDEMR M-PAK LH IMMUNOENZYMETRIC ASSAY receive FDA 510(k) clearance?

TANDEMR M-PAK LH IMMUNOENZYMETRIC ASSAY received FDA 510(k) clearance on 1987-08-25, under 510(k) number K872131.

Who is the listed applicant for TANDEMR M-PAK LH 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 TANDEMR M-PAK LH IMMUNOENZYMETRIC ASSAY?

The FDA product code for TANDEMR M-PAK LH IMMUNOENZYMETRIC ASSAY 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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