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510(k) K003845

MODIFICATION TO INSTANT-VIEW METHAMPHETAMINE (METH 1000) URINE TEST (DIP STRIP) by Alfa Scientific Designs, Inc. — Product Code LAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 2001
Date Received
December 12, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gas Chromatography, Methamphetamine
Device Class
Class II
Regulation Number
862.3610
Review Panel
TX
Submission Type

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  • K131645 — INSTANT-VIEW MULTI-DRUG OF ABUSE URINE TEST (CUP, PANEL CASSETTE) (October 7, 2013)
  • K100051 — INSTANT-VIEW MILTI-DRUG OF ABUSE URINE TEST (PANEL, CUP), INSTANT-VERDICT MULTI- (July 6, 2010)
  • K070660 — INSTANT-VIEW FECAL OCCULT BLOOD (FOB) RAPID TEST (June 21, 2007)
  • K063545 — MULTI-DRUG OF ABUSE URINE TEST,URINE CUP TEST, AMPHETAMINE URINE TEST(CASSETTE, (May 7, 2007)
  • K060527 — INSTANT-VIEW BUP/NBUP URINE TEST. INSTANT-VERDICT BUP/NBUP URINE TEST; INSTANT (July 25, 2006)
  • K042227 — INSTANT-VIEW TROPONIN I TEST (November 19, 2004)
  • K024360 — INSTANT-VIEW H. PYLORI ONE STEP RAPID TEST (June 10, 2003)

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