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FDA 510(k)

MEDIX BIOTECH BESTEST HCG-URINE TEST KIT

K-Number: K932758 · 1993-09-28

ApplicantMedix Biotech, Inc.
Decision Date1993-09-28
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MEDIX BIOTECH BESTEST HCG-URINE TEST KIT 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 1993-09-28 under 510(k) number K932758. 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 MEDIX BIOTECH BESTEST HCG-URINE TEST KIT?

MEDIX BIOTECH BESTEST HCG-URINE TEST KIT is a medical device that received FDA 510(k) clearance on 1993-09-28. The listed applicant is Medix Biotech, Inc.. The 510(k) number is K932758.

When did MEDIX BIOTECH BESTEST HCG-URINE TEST KIT receive FDA 510(k) clearance?

MEDIX BIOTECH BESTEST HCG-URINE TEST KIT received FDA 510(k) clearance on 1993-09-28, under 510(k) number K932758.

Who is the listed applicant for MEDIX BIOTECH BESTEST HCG-URINE TEST KIT?

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 MEDIX BIOTECH BESTEST HCG-URINE TEST KIT?

The FDA product code for MEDIX BIOTECH BESTEST HCG-URINE TEST KIT 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)K952319CONTRAST & RAPID HCG URINE/SERUM TSTK932482MEDIX BIOTECH BESTEST STREP A CAT. NO. BSF1010K925436MEDIX 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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