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FDA 510(k)

VISUAL SERUM/URINE HCG COMBO KIT

K-Number: K852437 · 1985-07-12

ApplicantAmerican Bioclinical, Inc.
Decision Date1985-07-12
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VISUAL SERUM/URINE HCG COMBO KIT is the device name listed in this FDA 510(k) record. The listed applicant is American Bioclinical, Inc.. It received FDA 510(k) clearance on 1985-07-12 under 510(k) number K852437. 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 VISUAL SERUM/URINE HCG COMBO KIT?

VISUAL SERUM/URINE HCG COMBO KIT is a medical device that received FDA 510(k) clearance on 1985-07-12. The listed applicant is American Bioclinical, Inc.. The 510(k) number is K852437.

When did VISUAL SERUM/URINE HCG COMBO KIT receive FDA 510(k) clearance?

VISUAL SERUM/URINE HCG COMBO KIT received FDA 510(k) clearance on 1985-07-12, under 510(k) number K852437.

Who is the listed applicant for VISUAL SERUM/URINE HCG COMBO KIT?

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

What is the FDA product code for VISUAL SERUM/URINE HCG COMBO KIT?

The FDA product code for VISUAL SERUM/URINE HCG COMBO KIT 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 American Bioclinical, 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.

K852939CORTISOL SYSTEM BY EIAK852376SIMULTANEOUS LH/FSH SYSTEM BY RIAK851330PROLACTIN SYSTEM BY RIA

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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