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FDA 510(k)

QUICKCARD PRO HCG TEST, MODEL 9008

K-Number: K980896 · 1998-04-02

ApplicantPhamatech
Decision Date1998-04-02
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

QUICKCARD PRO HCG TEST, MODEL 9008 is the device name listed in this FDA 510(k) record. The listed applicant is Phamatech. It received FDA 510(k) clearance on 1998-04-02 under 510(k) number K980896. 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 QUICKCARD PRO HCG TEST, MODEL 9008?

QUICKCARD PRO HCG TEST, MODEL 9008 is a medical device that received FDA 510(k) clearance on 1998-04-02. The listed applicant is Phamatech. The 510(k) number is K980896.

When did QUICKCARD PRO HCG TEST, MODEL 9008 receive FDA 510(k) clearance?

QUICKCARD PRO HCG TEST, MODEL 9008 received FDA 510(k) clearance on 1998-04-02, under 510(k) number K980896.

Who is the listed applicant for QUICKCARD PRO HCG TEST, MODEL 9008?

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

What is the FDA product code for QUICKCARD PRO HCG TEST, MODEL 9008?

The FDA product code for QUICKCARD PRO HCG TEST, MODEL 9008 is JHI.

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Other records listing Phamatech 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.

K041578QUICKSCREEN, MODELS 9177X AND 9178XK030447AT HOME DRUG CUP, MODEL 9150XK010833AT WORK DRUG TEST, MODEL 9177T AWTK010836AT WORK DRUG TEST, MODEL 9147T AWTK010653AT HOME DRUG TEST, MODEL 9068 TK010655AT HOME DRUG TESTT, MODEL 9150 T

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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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