Company ยท US
Acro Biotech, LLC
FDA 510(k) clearances and medical device recalls filed under this name, 2006 to 2018. Name variants (Inc, Corp, punctuation) are merged.
10510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DJC | Thin Layer Chromatography, Methamphetamine | 2 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 2 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 1 |
| DJG | Enzyme Immunoassay, Opiates | 1 |
| DKZ | Enzyme Immunoassay, Amphetamine | 1 |
| JXM | Enzyme Immunoassay, Benzodiazepine | 1 |
| LCM | Enzyme Immunoassay, Phencyclidine | 1 |
| LDJ | Enzyme Immunoassay, Cannabinoids | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 18, 2018 | K180771 | Acro HCG Pregnancy Rapid Test Acro Biotech, Inc. | LCX |
| Feb 2, 2018 | K172512 | ACRO HCG Pregnancy Rapid Test Acro Biotech, Inc. | LCX |
| Aug 7, 2006 | K060355 | ACRO BIOTECH LLC RAPID MDMA URINE TEST, CATALOG MDMA0010000 Acro Biotech, LLC | DJC |
| Jul 28, 2006 | K060354 | ACRO BIOTECH LLC RAPID BENZODIAZEPINE URINE TEST, CATALOG BZD001000 Acro Biotech, LLC | JXM |
| Jun 15, 2006 | K053037 | ACRO BIOTECH LLC RAPID OPIATES URINE TEST; CATALOG# OPI00100 Acro Biotech, LLC | DJG |
| Jun 6, 2006 | K053034 | ACRO BIOTECH LLC RAPID TETRAHYDROCANNABINOL URINE TEST; CATALOG# OPI001000 Acro Biotech, LLC | LDJ |
| Jun 6, 2006 | K053033 | ACRO BIOTECH LLC RAPID METHAMPHETAMINE URINE TEST; CATALOG# MET001000 Acro Biotech, LLC | DJC |
| May 5, 2006 | K053035 | ACRO BIOTECH LLC RAPID BENZOYLECGONINE URINE TEST; CATALOG# MET001000 Acro Biotech, LLC | DIO |
| May 3, 2006 | K060353 | ACRO RAPID PHENCYCLIDINE URINE TEST, CATALOG PCP001000 Acro Biotech, LLC | LCM |
| Feb 9, 2006 | K053032 | ACRO BIOTECH LLC RAPID AMPHETAMINE URINE TEST; CATALOG# AMP001000 Acro Biotech, LLC | DKZ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||