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510(k) K972577

QUICK SCREEN ONE STEP AMPHETAMINE TEST by Phamatech — Product Code DIT

K972577 is an FDA 510(k) premarket notification submitted by Phamatech for the device "QUICK SCREEN ONE STEP AMPHETAMINE TEST". The FDA issued a decision of Substantially Equivalent on August 20, 1997. The device falls under product code DIT (Thin Layer Chromatography, Amphetamine), a Class II device regulated under 21 CFR 862.3100. Phamatech has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 1997
Date Received
July 10, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Thin Layer Chromatography, Amphetamine
Device Class
Class II
Regulation Number
862.3100
Review Panel
TX
Submission Type

Other clearances by Phamatech

  • K181945 — QuickScreen Pro Multi Drug Screening Test, Model 9395Z (October 18, 2018)
  • K131069 — QUICKSCREEN AMPHETINE 500 TEST (May 14, 2014)
  • K103295 — QUICKSCREEN COCAINE 150 SCREENING TEST (February 1, 2012)
  • K070098 — QUICKSCREEN BARBITURATE 300 SCREENING TEST, MODELS 9019, 9018; MULTI DRUG SCREEN (December 7, 2007)
  • K070009 — AT HOME DRUG TEST MODELS, 9308T AND 9308X (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)

Other clearances for product code DIT

  • K910525 — MICROLINE SCREEN FOR METHAMPHETAMINE (April 5, 1991)
  • K901276 — HEMACON-DOA(TM) DRUGS OF ABUSE WHOLE BLOOD CONTROL (April 26, 1990)
  • K790805 — DRUG ABUSE DIPSTICKS (June 6, 1979)

FDA data resources