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510(k) K053033

ACRO BIOTECH LLC RAPID METHAMPHETAMINE URINE TEST; CATALOG# MET001000 by Acro Biotech, LLC — Product Code DJC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 2006
Date Received
October 27, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Acro Biotech, LLC

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  • K060354 — ACRO BIOTECH LLC RAPID BENZODIAZEPINE URINE TEST, CATALOG BZD001000 (July 28, 2006)
  • K053037 — ACRO BIOTECH LLC RAPID OPIATES URINE TEST; CATALOG# OPI00100 (June 15, 2006)
  • K053034 — ACRO BIOTECH LLC RAPID TETRAHYDROCANNABINOL URINE TEST; CATALOG# OPI001000 (June 6, 2006)
  • K053035 — ACRO BIOTECH LLC RAPID BENZOYLECGONINE URINE TEST; CATALOG# MET001000 (May 5, 2006)
  • K060353 — ACRO RAPID PHENCYCLIDINE URINE TEST, CATALOG PCP001000 (May 3, 2006)
  • K053032 — ACRO BIOTECH LLC RAPID AMPHETAMINE URINE TEST; CATALOG# AMP001000 (February 9, 2006)

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