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FDA 510(k)

TERUMO SENSIBEAD EIA FSH KIT

K-Number: K863928 · 1986-12-04

ApplicantTerumo Medical Corp.
Decision Date1986-12-04
Product CodeCGJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TERUMO SENSIBEAD EIA FSH KIT is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Medical Corp.. It received FDA 510(k) clearance on 1986-12-04 under 510(k) number K863928. 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 TERUMO SENSIBEAD EIA FSH KIT?

TERUMO SENSIBEAD EIA FSH KIT is a medical device that received FDA 510(k) clearance on 1986-12-04. The listed applicant is Terumo Medical Corp.. The 510(k) number is K863928.

When did TERUMO SENSIBEAD EIA FSH KIT receive FDA 510(k) clearance?

TERUMO SENSIBEAD EIA FSH KIT received FDA 510(k) clearance on 1986-12-04, under 510(k) number K863928.

Who is the listed applicant for TERUMO SENSIBEAD EIA FSH KIT?

The FDA 510(k) record lists Terumo Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TERUMO SENSIBEAD EIA FSH KIT?

The FDA product code for TERUMO SENSIBEAD EIA FSH KIT is CGJ.

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Other records listing Terumo Medical Corp. 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.

K111606PINNACLE PRECISION ACCESS SYSTEMK111556GLIDECROSS SUPPORT CATHETERK110540TERUMO SUPPORT CATHETERK102008GLIDESHEATHK091329PINNACLE DESTINATION PERIPHERAL GUIDING SHEATHK082997TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETER

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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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