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FDA 510(k)

PRECISE TM HCG

K-Number: K915197 · 1991-12-17

ApplicantBecton Dickinson Advanced Diagnostics
Decision Date1991-12-17
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PRECISE TM HCG is the device name listed in this FDA 510(k) record. The listed applicant is Becton Dickinson Advanced Diagnostics. It received FDA 510(k) clearance on 1991-12-17 under 510(k) number K915197. 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 PRECISE TM HCG?

PRECISE TM HCG is a medical device that received FDA 510(k) clearance on 1991-12-17. The listed applicant is Becton Dickinson Advanced Diagnostics. The 510(k) number is K915197.

When did PRECISE TM HCG receive FDA 510(k) clearance?

PRECISE TM HCG received FDA 510(k) clearance on 1991-12-17, under 510(k) number K915197.

Who is the listed applicant for PRECISE TM HCG?

The FDA 510(k) record lists Becton Dickinson Advanced Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRECISE TM HCG?

The FDA product code for PRECISE TM HCG is JHI.

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Other records listing Becton Dickinson Advanced Diagnostics 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.

K935667QTEST(R) STREPK931294IQ TUPTAKE ASSAYK931295IQ TT4 ASSAYK926356PRECISE(TM) HCG(URINE/SERUM) AND PRCISE(TM) PREGK925132BECTON DICKINSON THYROID STIMULATING HORMONE SYSTEK923673PRECISE STREP A

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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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