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510(k) K181945

QuickScreen Pro Multi Drug Screening Test, Model 9395Z by Phamatech, Inc. — Product Code DKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 2018
Date Received
July 20, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Amphetamine
Device Class
Class II
Regulation Number
862.3100
Review Panel
TX
Submission Type

Other clearances by Phamatech, Inc.

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  • K070009 — AT HOME DRUG TEST MODELS, 9308T AND 9308X (December 7, 2007)
  • K070098 — QUICKSCREEN BARBITURATE 300 SCREENING TEST, MODELS 9019, 9018; MULTI DRUG SCREEN (December 7, 2007)
  • K043599 — MOMENTS MENOPAUSE CHECK, MODEL 9113 (February 25, 2005)
  • K043051 — QUICKSCREEN OXYCODONE TEST, MODELS 9120, 9120T, 9120X AND 9121 (February 7, 2005)
  • K043167 — PHAMATECH QUICKSCREEN BENZODIAZEPINES TEST, MODELS 9025, 9026, 9027T, 9153T AND (December 29, 2004)
  • K041578 — QUICKSCREEN, MODELS 9177X AND 9178X (September 10, 2004)
  • K040575 — PHARMATECH MENOPAUSE CHECK, MODELS 9111 AND 9112 (May 20, 2004)
  • K030447 — AT HOME DRUG CUP, MODEL 9150X (April 14, 2003)

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