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)

UBI MAGIWEL(TM) LH QUANTITATIVE & QUALITATIVE

K-Number: K863442 · 1987-02-04

ApplicantUnited Biotech, Inc.
Decision Date1987-02-04
Product CodeCEP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

UBI MAGIWEL(TM) LH QUANTITATIVE & QUALITATIVE is the device name listed in this FDA 510(k) record. The listed applicant is United Biotech, Inc.. It received FDA 510(k) clearance on 1987-02-04 under 510(k) number K863442. 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 UBI MAGIWEL(TM) LH QUANTITATIVE & QUALITATIVE?

UBI MAGIWEL(TM) LH QUANTITATIVE & QUALITATIVE is a medical device that received FDA 510(k) clearance on 1987-02-04. The listed applicant is United Biotech, Inc.. The 510(k) number is K863442.

When did UBI MAGIWEL(TM) LH QUANTITATIVE & QUALITATIVE receive FDA 510(k) clearance?

UBI MAGIWEL(TM) LH QUANTITATIVE & QUALITATIVE received FDA 510(k) clearance on 1987-02-04, under 510(k) number K863442.

Who is the listed applicant for UBI MAGIWEL(TM) LH QUANTITATIVE & QUALITATIVE?

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

What is the FDA product code for UBI MAGIWEL(TM) LH QUANTITATIVE & QUALITATIVE?

The FDA product code for UBI MAGIWEL(TM) LH QUANTITATIVE & QUALITATIVE 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 United Biotech, 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.

K981573UBI MAGIWEL PAP (PROSTATIC ACID PHOSPHATASE) EIA QUANTITATVEK973154UBI MAGIWEL MARIJUANA METABOLITESK973692UBI MAGIWEL C-REACTIVE PROTEIN(CRP) QUANTITATIVEK973156UBI MAGIWEL COCAINE METABOLITESK973155UBI MAGIWEL OPIATE METABOLITESK973153UBI MAGIWEL AMPHETAMINE METABOLITES

View all 22 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 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.

↑