Acro Biotech, LLC: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Acro Biotech, LLC” (first 2006, latest 2018), across 8 product codes in 2 review panels. Median 510(k) review time under this name: 170 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 2 | 110 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Acro Biotech, LLC took a median 110 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 150 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DJC | Thin Layer Chromatography, Methamphetamine | 2 | 2 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 2 | 2 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 1 | 1 |
| DJG | Enzyme Immunoassay, Opiates | 1 | 1 |
| DKZ | Enzyme Immunoassay, Amphetamine | 1 | 1 |
| JXM | Enzyme Immunoassay, Benzodiazepine | 1 | 1 |
| LCM | Enzyme Immunoassay, Phencyclidine | 1 | 1 |
| LDJ | Enzyme Immunoassay, Cannabinoids | 1 | 1 |
Review panels
Most recent Acro Biotech, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K180771 | Acro HCG Pregnancy Rapid Test | LCX | 2018-05-18 | 56 |
| K172512 | ACRO HCG Pregnancy Rapid Test | LCX | 2018-02-02 | 165 |
| K060355 | ACRO BIOTECH LLC RAPID MDMA URINE TEST, CATALOG MDMA0010000 | DJC | 2006-08-07 | 175 |
| K060354 | ACRO BIOTECH LLC RAPID BENZODIAZEPINE URINE TEST, CATALOG BZD001000 | JXM | 2006-07-28 | 165 |
| K053037 | ACRO BIOTECH LLC RAPID OPIATES URINE TEST; CATALOG# OPI00100 | DJG | 2006-06-15 | 231 |
| K053034 | ACRO BIOTECH LLC RAPID TETRAHYDROCANNABINOL URINE TEST; CATALOG# OPI001000 | LDJ | 2006-06-06 | 222 |
| K053033 | ACRO BIOTECH LLC RAPID METHAMPHETAMINE URINE TEST; CATALOG# MET001000 | DJC | 2006-06-06 | 222 |
| K053035 | ACRO BIOTECH LLC RAPID BENZOYLECGONINE URINE TEST; CATALOG# MET001000 | DIO | 2006-05-05 | 190 |
| K060353 | ACRO RAPID PHENCYCLIDINE URINE TEST, CATALOG PCP001000 | LCM | 2006-05-03 | 79 |
| K053032 | ACRO BIOTECH LLC RAPID AMPHETAMINE URINE TEST; CATALOG# AMP001000 | DKZ | 2006-02-09 | 105 |
Recalls
openFDA lists no recalls under a recalling firm named Acro Biotech, LLC.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Acro Biomedical Co., Ltd. (4 510(k)s)
- Acro Composites, LLC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Acro Biotech, LLC?
FDA lists 10 510(k) clearances under the applicant name “Acro Biotech, LLC” (first 2006, latest 2018), across 8 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Acro Biotech, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Acro Biotech, LLC is 170 days.
Which FDA product codes appear under Acro Biotech, LLC?
The most frequent FDA product codes under this applicant name are DJC (Thin Layer Chromatography, Methamphetamine, 2); LCX (Kit, Test, Pregnancy, Hcg, Over The Counter, 2); DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites, 1).
Next steps
- See all 10 Acro Biotech, LLC clearances with predicates and recalls
- Run predicate analysis for product code DJC, Acro Biotech, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.