Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Acro Biotech, LLC · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
190 daysmedian FDA review time
231 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K060355 | ACRO BIOTECH LLC RAPID MDMA URINE TEST, CATALOG MDMA0010000 | Acro Biotech, LLC | 2006-08-07 | 175 | 0 |
| K060354 | ACRO BIOTECH LLC RAPID BENZODIAZEPINE URINE TEST, CATALOG BZ | Acro Biotech, LLC | 2006-07-28 | 165 | 0 |
| K053037 | ACRO BIOTECH LLC RAPID OPIATES URINE TEST; CATALOG# OPI00100 | Acro Biotech, LLC | 2006-06-15 | 231 | 0 |
| K053033 | ACRO BIOTECH LLC RAPID METHAMPHETAMINE URINE TEST; CATALOG# | Acro Biotech, LLC | 2006-06-06 | 222 | 0 |
| K053034 | ACRO BIOTECH LLC RAPID TETRAHYDROCANNABINOL URINE TEST; CATA | Acro Biotech, LLC | 2006-06-06 | 222 | 0 |
| K053035 | ACRO BIOTECH LLC RAPID BENZOYLECGONINE URINE TEST; CATALOG# | Acro Biotech, LLC | 2006-05-05 | 190 | 0 |
| K060353 | ACRO RAPID PHENCYCLIDINE URINE TEST, CATALOG PCP001000 | Acro Biotech, LLC | 2006-05-03 | 79 | 0 |
| K053032 | ACRO BIOTECH LLC RAPID AMPHETAMINE URINE TEST; CATALOG# AMP0 | Acro Biotech, LLC | 2006-02-09 | 105 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda