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FDA 510(k)

O.P.T.(TM) OVULATION PREDICTION TEST

K-Number: K870584 · 1987-11-25

ApplicantWarner-Lambert Co.
Decision Date1987-11-25
Product CodeCEP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

O.P.T.(TM) OVULATION PREDICTION TEST is the device name listed in this FDA 510(k) record. The listed applicant is Warner-Lambert Co.. It received FDA 510(k) clearance on 1987-11-25 under 510(k) number K870584. 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 O.P.T.(TM) OVULATION PREDICTION TEST?

O.P.T.(TM) OVULATION PREDICTION TEST is a medical device that received FDA 510(k) clearance on 1987-11-25. The listed applicant is Warner-Lambert Co.. The 510(k) number is K870584.

When did O.P.T.(TM) OVULATION PREDICTION TEST receive FDA 510(k) clearance?

O.P.T.(TM) OVULATION PREDICTION TEST received FDA 510(k) clearance on 1987-11-25, under 510(k) number K870584.

Who is the listed applicant for O.P.T.(TM) OVULATION PREDICTION TEST?

The FDA 510(k) record lists Warner-Lambert Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for O.P.T.(TM) OVULATION PREDICTION TEST?

The FDA product code for O.P.T.(TM) OVULATION PREDICTION TEST is CEP.

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Other records listing Warner-Lambert Co. 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.

K024160NEOSPORIN SCAR SOLUTIONK893452EXTRA STRENGTH EFFERGRIP DENTURE ADHESIVE CREAMK861510MULTILUMEN VIAPIC CENTRAL LINE CATHETERK852967GENERAL DIAGNOSTICS' CEFTRIAXONE 30MCG SUSDEP DISKK852689GENERAL DIAGNOSTICS CEFTAZIDIME 30 MCG SUSC DISKK852843GENERAL DIAGNOSTICS COAG-A-MATE XC

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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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