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FDA 510(k)

CONTRAST & RAPID HCG URINE/SERUM TST

K-Number: K952319 · 1995-06-20

ApplicantMedix Biotech, Inc.
Decision Date1995-06-20
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CONTRAST & RAPID HCG URINE/SERUM TST is the device name listed in this FDA 510(k) record. The listed applicant is Medix Biotech, Inc.. It received FDA 510(k) clearance on 1995-06-20 under 510(k) number K952319. 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 & RAPID HCG URINE/SERUM TST?

CONTRAST & RAPID HCG URINE/SERUM TST is a medical device that received FDA 510(k) clearance on 1995-06-20. The listed applicant is Medix Biotech, Inc.. The 510(k) number is K952319.

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

CONTRAST & RAPID HCG URINE/SERUM TST received FDA 510(k) clearance on 1995-06-20, under 510(k) number K952319.

Who is the listed applicant for CONTRAST & RAPID HCG URINE/SERUM TST?

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

What is the FDA product code for CONTRAST & RAPID HCG URINE/SERUM TST?

The FDA product code for CONTRAST & RAPID HCG URINE/SERUM TST is JHI.

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Other records listing Medix Biotech, 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.

K952873MEDIX BIOTECH STREP A ANTIGEN DETECTION TEST (MODIFICATION)K932482MEDIX BIOTECH BESTEST STREP A CAT. NO. BSF1010K932758MEDIX BIOTECH BESTEST HCG-URINE TEST KITK925436MEDIX BIOTECH TOTAL T3 ENZYME IMMUNOASSAY TEST KITK924259MEDIX BIOTECH BESTEST(TM) HCG-URINE, CAT# B1H0100K922047IGE ENZYME IMMUNOASSAY TEST KIT CAT.NO. KIF4064

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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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