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FDA 510(k)

QUICKSCREEN, MODELS 9177X AND 9178X

K-Number: K041578 · 2004-09-10

ApplicantPhamatech
Decision Date2004-09-10
Product CodeLCM
DecisionSubstantially Equivalent

Device Summary

QUICKSCREEN, MODELS 9177X AND 9178X is the device name listed in this FDA 510(k) record. The listed applicant is Phamatech. It received FDA 510(k) clearance on 2004-09-10 under 510(k) number K041578. The device is classified under product code LCM. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUICKSCREEN, MODELS 9177X AND 9178X?

QUICKSCREEN, MODELS 9177X AND 9178X is a medical device that received FDA 510(k) clearance on 2004-09-10. The listed applicant is Phamatech. The 510(k) number is K041578.

When did QUICKSCREEN, MODELS 9177X AND 9178X receive FDA 510(k) clearance?

QUICKSCREEN, MODELS 9177X AND 9178X received FDA 510(k) clearance on 2004-09-10, under 510(k) number K041578.

Who is the listed applicant for QUICKSCREEN, MODELS 9177X AND 9178X?

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, MODELS 9177X AND 9178X?

The FDA product code for QUICKSCREEN, MODELS 9177X AND 9178X is LCM.

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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 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.

K030447AT 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 TK010654AT HOME DRUG TEST, MODEL 9078 T

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Related Devices (Code: LCM)

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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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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