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510(k) K060353

ACRO RAPID PHENCYCLIDINE URINE TEST, CATALOG PCP001000 by Acro Biotech, LLC — Product Code LCM

K060353 is an FDA 510(k) premarket notification submitted by Acro Biotech, LLC for the device "ACRO RAPID PHENCYCLIDINE URINE TEST, CATALOG PCP001000". The FDA issued a decision of Substantially Equivalent on May 3, 2006. The device falls under product code LCM (Enzyme Immunoassay, Phencyclidine), a Class U device. Acro Biotech, LLC has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 2006
Date Received
February 13, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Phencyclidine
Device Class
Class U
Regulation Number
Review Panel
TX
Submission Type

Other clearances by Acro Biotech, LLC

  • K180771 — Acro HCG Pregnancy Rapid Test (May 18, 2018)
  • 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)
  • 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)
  • K053033 — ACRO BIOTECH LLC RAPID METHAMPHETAMINE URINE TEST; CATALOG# MET001000 (June 6, 2006)
  • K053035 — ACRO BIOTECH LLC RAPID BENZOYLECGONINE URINE TEST; CATALOG# MET001000 (May 5, 2006)
  • K053032 — ACRO BIOTECH LLC RAPID AMPHETAMINE URINE TEST; CATALOG# AMP001000 (February 9, 2006)

Other clearances for product code LCM

  • K212952 — Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in Hair (April 18, 2022)
  • K203489 — SEFRIA PCP Oral Fluid Enzyme Immunoassay (April 20, 2021)
  • K181135 — Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay (January 24, 2019)
  • K163220 — Atellica CH Phencyclidine (Pcp) (April 6, 2017)
  • K152176 — Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators (September 4, 2015)
  • K142044 — CR3 KEYLESS SPLIT SAMPLE CUP PHENCYCLIDIEN - METHYLENEDIOXYMETHAMPHETAMINE (August 25, 2014)
  • K131181 — OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY PHENCYCLIDINE (June 25, 2013)
  • K122703 — RAPIDFRET ORAL FLUID ASSAY FOR PCP, PCP CALIBRATOR SET, PCP CONTROL SET AND RAP (April 25, 2013)
  • K111928 — PSYCHEMEDICS PHENCYCLIDINE EIA (May 1, 2012)
  • K101746 — THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAY (April 8, 2011)

FDA data resources