FDA 510(k)

MEDIX BIOTECH BESTEST(TM) HCG-URINE, CAT# B1H0100

K-Number: K924259 · 1992-11-25

Decision Date1992-11-25

Product CodeJHI

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

MEDIX BIOTECH BESTEST(TM) HCG-URINE, CAT# B1H0100 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 1992-11-25 under 510(k) number K924259. 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(TM) HCG-URINE, CAT# B1H0100?

MEDIX BIOTECH BESTEST(TM) HCG-URINE, CAT# B1H0100 is a medical device that received FDA 510(k) clearance on 1992-11-25. The listed applicant is Medix Biotech, Inc.. The 510(k) number is K924259.

When did MEDIX BIOTECH BESTEST(TM) HCG-URINE, CAT# B1H0100 receive FDA 510(k) clearance?

MEDIX BIOTECH BESTEST(TM) HCG-URINE, CAT# B1H0100 received FDA 510(k) clearance on 1992-11-25, under 510(k) number K924259.

Who is the listed applicant for MEDIX BIOTECH BESTEST(TM) HCG-URINE, CAT# B1H0100?

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(TM) HCG-URINE, CAT# B1H0100?

The FDA product code for MEDIX BIOTECH BESTEST(TM) HCG-URINE, CAT# B1H0100 is JHI.

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Other records listing Medix Biotech, Inc. as applicant

K952873MEDIX BIOTECH STREP A ANTIGEN DETECTION TEST (MODIFICATION)K952319CONTRAST & RAPID HCG URINE/SERUM TST K932482MEDIX BIOTECH BESTEST STREP A CAT. NO. BSF1010 K932758MEDIX BIOTECH BESTEST HCG-URINE TEST KIT K925436MEDIX BIOTECH TOTAL T3 ENZYME IMMUNOASSAY TEST KIT K922047IGE ENZYME IMMUNOASSAY TEST KIT CAT.NO. KIF4064

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Related Devices (Code: JHI)

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.