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FDA 510(k)

CONTRAST HCG URINE/SERUM TEST AND RAPID HCG URINE/SERUM TEST

K-Number: K964155 · 1996-11-25

ApplicantGenzyme Diagnostics
Decision Date1996-11-25
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CONTRAST HCG URINE/SERUM TEST AND RAPID HCG URINE/SERUM TEST is the device name listed in this FDA 510(k) record. The listed applicant is Genzyme Diagnostics. It received FDA 510(k) clearance on 1996-11-25 under 510(k) number K964155. 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 CONTRAST HCG URINE/SERUM TEST AND RAPID HCG URINE/SERUM TEST?

CONTRAST HCG URINE/SERUM TEST AND RAPID HCG URINE/SERUM TEST is a medical device that received FDA 510(k) clearance on 1996-11-25. The listed applicant is Genzyme Diagnostics. The 510(k) number is K964155.

When did CONTRAST HCG URINE/SERUM TEST AND RAPID HCG URINE/SERUM TEST receive FDA 510(k) clearance?

CONTRAST HCG URINE/SERUM TEST AND RAPID HCG URINE/SERUM TEST received FDA 510(k) clearance on 1996-11-25, under 510(k) number K964155.

Who is the listed applicant for CONTRAST HCG URINE/SERUM TEST AND RAPID HCG URINE/SERUM TEST?

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

What is the FDA product code for CONTRAST HCG URINE/SERUM TEST AND RAPID HCG URINE/SERUM TEST?

The FDA product code for CONTRAST HCG URINE/SERUM TEST AND RAPID HCG URINE/SERUM TEST is JHI.

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Other records listing Genzyme 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.

K043385OSOM HCG COMBO TESTK983399GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAYK963425GENZYME DIAGNOSTICS CONTRAST MONOK964156CONTRAST STRIP HCG

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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