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FDA 510(k)

UBI MAGIWEL(TM) FSH QUANTITATIVE

K-Number: K864080 · 1986-11-13

ApplicantUnited Biotech, Inc.
Decision Date1986-11-13
Product CodeCGJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

UBI MAGIWEL(TM) FSH QUANTITATIVE 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 1986-11-13 under 510(k) number K864080. The device is classified under product code CGJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UBI MAGIWEL(TM) FSH QUANTITATIVE?

UBI MAGIWEL(TM) FSH QUANTITATIVE is a medical device that received FDA 510(k) clearance on 1986-11-13. The listed applicant is United Biotech, Inc.. The 510(k) number is K864080.

When did UBI MAGIWEL(TM) FSH QUANTITATIVE receive FDA 510(k) clearance?

UBI MAGIWEL(TM) FSH QUANTITATIVE received FDA 510(k) clearance on 1986-11-13, under 510(k) number K864080.

Who is the listed applicant for UBI MAGIWEL(TM) FSH QUANTITATIVE?

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) FSH QUANTITATIVE?

The FDA product code for UBI MAGIWEL(TM) FSH QUANTITATIVE is CGJ.

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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 METABOLITESK973153UBI MAGIWEL AMPHETAMINE METABOLITESK973155UBI MAGIWEL OPIATE METABOLITES

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Related Devices (Code: CGJ)

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.

K052662ONE STEP FSH MENOPAUSAL TESTInd Diagnostic, Inc.K043599MOMENTS MENOPAUSE CHECK, MODEL 9113Phamatech, Inc.K041165FSH MENOPAUSE PREDICTOR TESTACON Laboratories, Inc.K040575PHARMATECH MENOPAUSE CHECK, MODELS 9111 AND 9112Phamatech, Inc.K030058EARLYDETECT MENOPAUSE TEST FOR FSHEarly Detect, Inc.K002450GENUA MENOPAUSE MONITOR TEST KITGenua 1944, 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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