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FDA 510(k)

QUICKSCREEN PRO DRUG CUP, MODEL 9195X

K-Number: K001397 · 2000-05-26

ApplicantPhamatech
Decision Date2000-05-26
Product CodeDKZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

QUICKSCREEN PRO DRUG CUP, MODEL 9195X is the device name listed in this FDA 510(k) record. The listed applicant is Phamatech. It received FDA 510(k) clearance on 2000-05-26 under 510(k) number K001397. The device is classified under product code DKZ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUICKSCREEN PRO DRUG CUP, MODEL 9195X?

QUICKSCREEN PRO DRUG CUP, MODEL 9195X is a medical device that received FDA 510(k) clearance on 2000-05-26. The listed applicant is Phamatech. The 510(k) number is K001397.

When did QUICKSCREEN PRO DRUG CUP, MODEL 9195X receive FDA 510(k) clearance?

QUICKSCREEN PRO DRUG CUP, MODEL 9195X received FDA 510(k) clearance on 2000-05-26, under 510(k) number K001397.

Who is the listed applicant for QUICKSCREEN PRO DRUG CUP, MODEL 9195X?

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 QUICKSCREEN PRO DRUG CUP, MODEL 9195X?

The FDA product code for QUICKSCREEN PRO DRUG CUP, MODEL 9195X is DKZ.

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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 9150XK010836AT WORK DRUG TEST, MODEL 9147T AWTK010833AT WORK DRUG TEST, MODEL 9177T AWTK010655AT HOME DRUG TESTT, MODEL 9150 TK010653AT HOME DRUG TEST, MODEL 9068 T

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Related Devices (Code: DKZ)

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.

K240670DRI Ecstasy Plus AssayMicrogenics CorporationK233019AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel RxHangzhou AllTest Biotech Co., Ltd.K231137Xenta Drug Screen Cup, Xenta Drug Screen DipcardXenta Biomedical Science Co., Ltd.K200363Quidel Triage® TOX Drug Screen, 94600Quidel Cardiovascular, Inc.K191099Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test PanelAtlas MedicalK182719Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterProQuidel Cardiovascular, Inc.

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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