ACRO BIOTECH LLC RAPID MDMA URINE TEST, CATALOG MDMA0010000— 510(k) K060355
Substantially EquivalentAcro Biotech, LLC
FDA 510(k) clearance K060355 for ACRO BIOTECH LLC RAPID MDMA URINE TEST, CATALOG MDMA0010000, Substantially Equivalent on 2006-08-07. Applicant: Acro Biotech, LLC. Device class: 2.
Clearance details
- Applicant
- Acro Biotech, LLC
- Product code
- Code DJC
- Device class
- Class 2
- Regulation
- 21 CFR 862.3610
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rancho Cucamonga, CA, US
Recent devices under product code DJC
view all- K253705 — Healgen® Accurate Oral Fluid Drug Test
- K240287 — LYHER® Oral fluid Multi-Drug Test Kit (Cube)
- K180878 — BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Oxazepam Test Cassette for OTC Use, BIO-VENTURE Rapid Cocaine Test Cassette for OTC Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Morphine Test Cassette for OTC Use, BIO-VENTURE Rapid Marijuana Test Cassette for OTC Use, BIO-VENTURE Rapid Amphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Oxazepam Test Cassette for Rx Use, BIO-VENTURE Rapid Cocaine Test Cassette for Rx
- K181305 — OralTox Oral fluid Drug Test
- K171403 — OralTox Oral Fluid Drug Test
More clearances from Acro Biotech, LLC
view all- K060354 — ACRO BIOTECH LLC RAPID BENZODIAZEPINE URINE TEST, CATALOG BZD001000
- K053037 — ACRO BIOTECH LLC RAPID OPIATES URINE TEST; CATALOG# OPI00100
- K053033 — ACRO BIOTECH LLC RAPID METHAMPHETAMINE URINE TEST; CATALOG# MET001000
- K053034 — ACRO BIOTECH LLC RAPID TETRAHYDROCANNABINOL URINE TEST; CATALOG# OPI001000
- K053035 — ACRO BIOTECH LLC RAPID BENZOYLECGONINE URINE TEST; CATALOG# MET001000
Data sourced from openFDA. This site is unofficial and independent of the FDA.