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FDA 510(k)

DBEST ONE-STEP HCG SERUM/URINE TEST

K-Number: K973957 · 1997-12-17

ApplicantAmeritek, Inc.
Decision Date1997-12-17
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DBEST ONE-STEP HCG SERUM/URINE TEST is the device name listed in this FDA 510(k) record. The listed applicant is Ameritek, Inc.. It received FDA 510(k) clearance on 1997-12-17 under 510(k) number K973957. 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 DBEST ONE-STEP HCG SERUM/URINE TEST?

DBEST ONE-STEP HCG SERUM/URINE TEST is a medical device that received FDA 510(k) clearance on 1997-12-17. The listed applicant is Ameritek, Inc.. The 510(k) number is K973957.

When did DBEST ONE-STEP HCG SERUM/URINE TEST receive FDA 510(k) clearance?

DBEST ONE-STEP HCG SERUM/URINE TEST received FDA 510(k) clearance on 1997-12-17, under 510(k) number K973957.

Who is the listed applicant for DBEST ONE-STEP HCG SERUM/URINE TEST?

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

What is the FDA product code for DBEST ONE-STEP HCG SERUM/URINE TEST?

The FDA product code for DBEST ONE-STEP HCG SERUM/URINE TEST is JHI.

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Other records listing Ameritek, 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.

K001215DBEST HCG 2 IU/ML TEST KITK990873DBEST URINARY TRACT INFECTION TEST KIT FOR HOME-USEK990681DBSET MULTIDRUG SCREEN TEST KITK984269DBEST OCCULT BLOOD TEST KITK983191DBEST COCAINE TEST KITK983190DBEST OPIATES TEST KIT

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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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