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FDA 510(k)

ACCUSTRIP HCG-URINE MODEL NUMBER HCG-002

K-Number: K981838 · 1998-06-25

ApplicantUnotech Diagnostics, Inc.
Decision Date1998-06-25
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACCUSTRIP HCG-URINE MODEL NUMBER HCG-002 is the device name listed in this FDA 510(k) record. The listed applicant is Unotech Diagnostics, Inc.. It received FDA 510(k) clearance on 1998-06-25 under 510(k) number K981838. 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 ACCUSTRIP HCG-URINE MODEL NUMBER HCG-002?

ACCUSTRIP HCG-URINE MODEL NUMBER HCG-002 is a medical device that received FDA 510(k) clearance on 1998-06-25. The listed applicant is Unotech Diagnostics, Inc.. The 510(k) number is K981838.

When did ACCUSTRIP HCG-URINE MODEL NUMBER HCG-002 receive FDA 510(k) clearance?

ACCUSTRIP HCG-URINE MODEL NUMBER HCG-002 received FDA 510(k) clearance on 1998-06-25, under 510(k) number K981838.

Who is the listed applicant for ACCUSTRIP HCG-URINE MODEL NUMBER HCG-002?

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

What is the FDA product code for ACCUSTRIP HCG-URINE MODEL NUMBER HCG-002?

The FDA product code for ACCUSTRIP HCG-URINE MODEL NUMBER HCG-002 is JHI.

Related Clinical Trials

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.

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Other records listing Unotech Diagnostics, 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.

K032987ACCUTEST HCG-COMBO MODEL,HCG-004, ACCUSTRIP HCG-COMBO MODEL, HCG-005K971886ACCUTEST HCG-URINE

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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