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FDA 510(k)

FIRST RESPONSE 10 MINUTE OVULATION PREDICTOR TEST

K-Number: K883530 · 1988-12-19

ApplicantTambrands, Inc.
Decision Date1988-12-19
Product CodeCEP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FIRST RESPONSE 10 MINUTE OVULATION PREDICTOR TEST is the device name listed in this FDA 510(k) record. The listed applicant is Tambrands, Inc.. It received FDA 510(k) clearance on 1988-12-19 under 510(k) number K883530. 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 FIRST RESPONSE 10 MINUTE OVULATION PREDICTOR TEST?

FIRST RESPONSE 10 MINUTE OVULATION PREDICTOR TEST is a medical device that received FDA 510(k) clearance on 1988-12-19. The listed applicant is Tambrands, Inc.. The 510(k) number is K883530.

When did FIRST RESPONSE 10 MINUTE OVULATION PREDICTOR TEST receive FDA 510(k) clearance?

FIRST RESPONSE 10 MINUTE OVULATION PREDICTOR TEST received FDA 510(k) clearance on 1988-12-19, under 510(k) number K883530.

Who is the listed applicant for FIRST RESPONSE 10 MINUTE OVULATION PREDICTOR TEST?

The FDA 510(k) record lists Tambrands, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FIRST RESPONSE 10 MINUTE OVULATION PREDICTOR TEST?

The FDA product code for FIRST RESPONSE 10 MINUTE OVULATION PREDICTOR TEST is CEP.

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Other records listing Tambrands, Inc. as applicant

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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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