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FDA 510(k)

OVUQUICK SELF-TEST (OVUQUICK; RAMP LH ASSAY)

K-Number: K871726 · 1987-07-27

ApplicantMonoclonal Antibodies, Inc.
Decision Date1987-07-27
Product CodeCEP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

OVUQUICK SELF-TEST (OVUQUICK; RAMP LH ASSAY) is the device name listed in this FDA 510(k) record. The listed applicant is Monoclonal Antibodies, Inc.. It received FDA 510(k) clearance on 1987-07-27 under 510(k) number K871726. 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 OVUQUICK SELF-TEST (OVUQUICK; RAMP LH ASSAY)?

OVUQUICK SELF-TEST (OVUQUICK; RAMP LH ASSAY) is a medical device that received FDA 510(k) clearance on 1987-07-27. The listed applicant is Monoclonal Antibodies, Inc.. The 510(k) number is K871726.

When did OVUQUICK SELF-TEST (OVUQUICK; RAMP LH ASSAY) receive FDA 510(k) clearance?

OVUQUICK SELF-TEST (OVUQUICK; RAMP LH ASSAY) received FDA 510(k) clearance on 1987-07-27, under 510(k) number K871726.

Who is the listed applicant for OVUQUICK SELF-TEST (OVUQUICK; RAMP LH ASSAY)?

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

What is the FDA product code for OVUQUICK SELF-TEST (OVUQUICK; RAMP LH ASSAY)?

The FDA product code for OVUQUICK SELF-TEST (OVUQUICK; RAMP LH ASSAY) is CEP.

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Other records listing Monoclonal Antibodies, 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.

K874863RAMP HERPES SIMPLEX VIRUS (HSV) (CCT)K863744HCG CONTROL KITK860924RAMP PROGESTURINE PDG ASSAY--48 TEST KITK854611RAMP URINE HCG ASSAYK850730MODEL SERUM HCG ASSAYK850480OVU STICK SELF-TEST -MODIFICATION

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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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