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FDA 510(k)

OBA(TM) SERUM HCG ASSAY

K-Number: K911047 · 1991-06-24

ApplicantAdeza Biomedical
Decision Date1991-06-24
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

OBA(TM) SERUM HCG ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Adeza Biomedical. It received FDA 510(k) clearance on 1991-06-24 under 510(k) number K911047. 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 OBA(TM) SERUM HCG ASSAY?

OBA(TM) SERUM HCG ASSAY is a medical device that received FDA 510(k) clearance on 1991-06-24. The listed applicant is Adeza Biomedical. The 510(k) number is K911047.

When did OBA(TM) SERUM HCG ASSAY receive FDA 510(k) clearance?

OBA(TM) SERUM HCG ASSAY received FDA 510(k) clearance on 1991-06-24, under 510(k) number K911047.

Who is the listed applicant for OBA(TM) SERUM HCG ASSAY?

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

What is the FDA product code for OBA(TM) SERUM HCG ASSAY?

The FDA product code for OBA(TM) SERUM HCG ASSAY is JHI.

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 Adeza Biomedical 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.

K911045OBA(TM) READERK900225ROMCHECK SPECIMEN COLLECTION KIT

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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