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FDA 510(k)

TERUMO SENSIBEAD(TM) EIA ESTRADIOL KIT

K-Number: K882343 · 1988-07-01

ApplicantTerumo Medical Corp.
Decision Date1988-07-01
Product CodeCHP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TERUMO SENSIBEAD(TM) EIA ESTRADIOL 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 1988-07-01 under 510(k) number K882343. The device is classified under product code CHP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TERUMO SENSIBEAD(TM) EIA ESTRADIOL KIT?

TERUMO SENSIBEAD(TM) EIA ESTRADIOL KIT is a medical device that received FDA 510(k) clearance on 1988-07-01. The listed applicant is Terumo Medical Corp.. The 510(k) number is K882343.

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

TERUMO SENSIBEAD(TM) EIA ESTRADIOL KIT received FDA 510(k) clearance on 1988-07-01, under 510(k) number K882343.

Who is the listed applicant for TERUMO SENSIBEAD(TM) EIA ESTRADIOL 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(TM) EIA ESTRADIOL KIT?

The FDA product code for TERUMO SENSIBEAD(TM) EIA ESTRADIOL KIT is CHP.

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.

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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: CHP)

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.

K041349LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF ESTRADIOL IN SALIVA AND SERUMIbl GmbHK97390117 B-ESTRADIOL (ELISA)Kmi Diagnostics, Inc.K973743ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZERBeckman Instruments, Inc.K970386ACS ESTADIOL-6 IIChiron Diagnostics Corp.K970643VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CALIBRATORS (GEM.C050)Johnson & Johnson Clinical Diagnostics, Inc.K970126ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (33550,33540,33545)Bio-Rad 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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