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FDA 510(k)

GENZYME CONTRAST II HCG URINE/SERUM TEST

K-Number: K023544 · 2003-01-16

ApplicantGenzyme Corp.
Decision Date2003-01-16
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GENZYME CONTRAST II HCG URINE/SERUM TEST is the device name listed in this FDA 510(k) record. The listed applicant is Genzyme Corp.. It received FDA 510(k) clearance on 2003-01-16 under 510(k) number K023544. 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 GENZYME CONTRAST II HCG URINE/SERUM TEST?

GENZYME CONTRAST II HCG URINE/SERUM TEST is a medical device that received FDA 510(k) clearance on 2003-01-16. The listed applicant is Genzyme Corp.. The 510(k) number is K023544.

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

GENZYME CONTRAST II HCG URINE/SERUM TEST received FDA 510(k) clearance on 2003-01-16, under 510(k) number K023544.

Who is the listed applicant for GENZYME CONTRAST II HCG URINE/SERUM TEST?

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

What is the FDA product code for GENZYME CONTRAST II HCG URINE/SERUM TEST?

The FDA product code for GENZYME CONTRAST II HCG URINE/SERUM TEST is JHI.

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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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