Acro Biotech, LLC

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
10
Inspections
2
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K180771Acro HCG Pregnancy Rapid TestMay 18, 2018
K172512ACRO HCG Pregnancy Rapid TestFebruary 2, 2018
K060355ACRO BIOTECH LLC RAPID MDMA URINE TEST, CATALOG MDMA0010000August 7, 2006
K060354ACRO BIOTECH LLC RAPID BENZODIAZEPINE URINE TEST, CATALOG BZD001000July 28, 2006
K053037ACRO BIOTECH LLC RAPID OPIATES URINE TEST; CATALOG# OPI00100June 15, 2006
K053034ACRO BIOTECH LLC RAPID TETRAHYDROCANNABINOL URINE TEST; CATALOG# OPI001000June 6, 2006
K053033ACRO BIOTECH LLC RAPID METHAMPHETAMINE URINE TEST; CATALOG# MET001000June 6, 2006
K053035ACRO BIOTECH LLC RAPID BENZOYLECGONINE URINE TEST; CATALOG# MET001000May 5, 2006
K060353ACRO RAPID PHENCYCLIDINE URINE TEST, CATALOG PCP001000May 3, 2006
K053032ACRO BIOTECH LLC RAPID AMPHETAMINE URINE TEST; CATALOG# AMP001000February 9, 2006