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FDA 510(k)

OVUSTICK SELF-TEST

K-Number: K843284 · 1984-12-11

ApplicantMonoclonal Antibodies, Inc.
Decision Date1984-12-11
Product CodeCEP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

OVUSTICK SELF-TEST 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 1984-12-11 under 510(k) number K843284. 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 OVUSTICK SELF-TEST?

OVUSTICK SELF-TEST is a medical device that received FDA 510(k) clearance on 1984-12-11. The listed applicant is Monoclonal Antibodies, Inc.. The 510(k) number is K843284.

When did OVUSTICK SELF-TEST receive FDA 510(k) clearance?

OVUSTICK SELF-TEST received FDA 510(k) clearance on 1984-12-11, under 510(k) number K843284.

Who is the listed applicant for OVUSTICK SELF-TEST?

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 OVUSTICK SELF-TEST?

The FDA product code for OVUSTICK SELF-TEST 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)K871726OVUQUICK SELF-TEST (OVUQUICK; RAMP LH ASSAY)K863744HCG CONTROL KITK860924RAMP PROGESTURINE PDG ASSAY--48 TEST KITK854611RAMP URINE HCG ASSAYK850730MODEL SERUM HCG ASSAY

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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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