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FDA 510(k)

ACCUTEST HCG-URINE

K-Number: K971886 · 1997-06-11

ApplicantUnotech Diagnostics, Inc.
Decision Date1997-06-11
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACCUTEST HCG-URINE 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 1997-06-11 under 510(k) number K971886. 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 ACCUTEST HCG-URINE?

ACCUTEST HCG-URINE is a medical device that received FDA 510(k) clearance on 1997-06-11. The listed applicant is Unotech Diagnostics, Inc.. The 510(k) number is K971886.

When did ACCUTEST HCG-URINE receive FDA 510(k) clearance?

ACCUTEST HCG-URINE received FDA 510(k) clearance on 1997-06-11, under 510(k) number K971886.

Who is the listed applicant for ACCUTEST HCG-URINE?

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 ACCUTEST HCG-URINE?

The FDA product code for ACCUTEST HCG-URINE 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-005K981838ACCUSTRIP HCG-URINE MODEL NUMBER HCG-002

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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