Acro Biotech LLC Rapid Tetrahydrocannabinol Urine Test; Catalog# OPI001000
FDA 510(k) K053034 · Acro Biotech, LLC
510(k) numberK053034
Submission
- Device name
- Acro Biotech LLC Rapid Tetrahydrocannabinol Urine Test; Catalog# OPI001000
- Applicant
- Acro Biotech, LLC
Rancho Cucamonga, CA, US - Received
- October 27, 2005
- Decision date
- June 6, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LDJ – Enzyme Immunoassay, Cannabinoids
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3870
- Specialty
- Clinical Toxicology
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Questions and answers
When was Acro Biotech LLC Rapid Tetrahydrocannabinol Urine Test; Catalog# OPI001000 cleared by the FDA?
Acro Biotech LLC Rapid Tetrahydrocannabinol Urine Test; Catalog# OPI001000 (K053034) received a 510(k) decision of Substantially Equivalent on June 6, 2006, 222 days after the submission was received.
What is the product code of K053034?
The FDA product code is LDJ – Enzyme Immunoassay, Cannabinoids, a Class II (moderate risk) device regulated under 21 CFR 862.3870.