Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

QUIK-CHECK OVULATION PREDICTOR

K-Number: K012252 · 2001-08-24

ApplicantACON Laboratories, Inc.
Decision Date2001-08-24
Product CodeCEP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

QUIK-CHECK OVULATION PREDICTOR is the device name listed in this FDA 510(k) record. The listed applicant is ACON Laboratories, Inc.. It received FDA 510(k) clearance on 2001-08-24 under 510(k) number K012252. 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 QUIK-CHECK OVULATION PREDICTOR?

QUIK-CHECK OVULATION PREDICTOR is a medical device that received FDA 510(k) clearance on 2001-08-24. The listed applicant is ACON Laboratories, Inc.. The 510(k) number is K012252.

When did QUIK-CHECK OVULATION PREDICTOR receive FDA 510(k) clearance?

QUIK-CHECK OVULATION PREDICTOR received FDA 510(k) clearance on 2001-08-24, under 510(k) number K012252.

Who is the listed applicant for QUIK-CHECK OVULATION PREDICTOR?

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

What is the FDA product code for QUIK-CHECK OVULATION PREDICTOR?

The FDA product code for QUIK-CHECK OVULATION PREDICTOR is CEP.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing ACON Laboratories, 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.

K261212Flowflex Plus RSV + Flu A/B + COVID Rapid TestK251697Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test StripK251749Flowflex Plus RSV + Flu A/B + COVID Home TestK250085On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring SystemK250377Flowflex Plus COVID-19 + Flu A/B Home TestK232715Distinct® Digital Pregnancy Test

View all 81 devices →

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 YorkK010244SURE CHECK OVULATION PREDICTORChembio Diagnostic Systems, 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.

↑