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510(k) K053037

ACRO BIOTECH LLC RAPID OPIATES URINE TEST; CATALOG# OPI00100 by Acro Biotech, LLC — Product Code DJG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 2006
Date Received
October 27, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Opiates
Device Class
Class II
Regulation Number
862.3650
Review Panel
TX
Submission Type

Other clearances by Acro Biotech, LLC

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  • K172512 — ACRO HCG Pregnancy Rapid Test (February 2, 2018)
  • K060355 — ACRO BIOTECH LLC RAPID MDMA URINE TEST, CATALOG MDMA0010000 (August 7, 2006)
  • K060354 — ACRO BIOTECH LLC RAPID BENZODIAZEPINE URINE TEST, CATALOG BZD001000 (July 28, 2006)
  • K053033 — ACRO BIOTECH LLC RAPID METHAMPHETAMINE URINE TEST; CATALOG# MET001000 (June 6, 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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