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FDA 510(k)

TANDEMR ICONR II HCG(SERUM) IMMUNOENZYMETRIC ASSAY

K-Number: K865057 · 1987-03-10

ApplicantHybritech, Inc.
Decision Date1987-03-10
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TANDEMR ICONR II HCG(SERUM) IMMUNOENZYMETRIC ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Hybritech, Inc.. It received FDA 510(k) clearance on 1987-03-10 under 510(k) number K865057. The device is classified under product code JHI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TANDEMR ICONR II HCG(SERUM) IMMUNOENZYMETRIC ASSAY?

TANDEMR ICONR II HCG(SERUM) IMMUNOENZYMETRIC ASSAY is a medical device that received FDA 510(k) clearance on 1987-03-10. The listed applicant is Hybritech, Inc.. The 510(k) number is K865057.

When did TANDEMR ICONR II HCG(SERUM) IMMUNOENZYMETRIC ASSAY receive FDA 510(k) clearance?

TANDEMR ICONR II HCG(SERUM) IMMUNOENZYMETRIC ASSAY received FDA 510(k) clearance on 1987-03-10, under 510(k) number K865057.

Who is the listed applicant for TANDEMR ICONR II HCG(SERUM) IMMUNOENZYMETRIC ASSAY?

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

What is the FDA product code for TANDEMR ICONR II HCG(SERUM) IMMUNOENZYMETRIC ASSAY?

The FDA product code for TANDEMR ICONR II HCG(SERUM) IMMUNOENZYMETRIC ASSAY is JHI.

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Other records listing Hybritech, 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.

K972666TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAYK961573TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAYK930810TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAYK922754TANDEM-E IGE II CALIBRATION VERIFICATION SETK921745HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNOK921252TANDEM-E FERRITIN CALIBRATION VERIFICATION CONROL

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Related Devices (Code: JHI)

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.

K262299Instant-View® hCG Combo II Cassette TestAlfa Scientific Designs, Inc.K241919Innovita HCG Pregnancy Rapid Combo TestInnovita (Tangshan) Biological Technology Co., Ltd.K203272Alltest Pregnancy Rapid Combo Test CassetteHangzhou AllTest Biotech Co., Ltd.K172322Atellica IM Total hCG (ThCG)Siemens Healthcare Diagnostics, Inc.K172257TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format)True Diagnostics, Inc.K152768Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test StripAssure Tech. Co., Ltd.

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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