Urine Cannabinoids (THC) Screen Flex Reagent Cartridge, Catalog No. DF 95A
FDA 510(k) K000461 · Dade Behring, Inc.
510(k) numberK000461
Submission
- Device name
- Urine Cannabinoids (THC) Screen Flex Reagent Cartridge, Catalog No. DF 95A
- Applicant
- Dade Behring, Inc.
Newark, DE, US - Received
- February 11, 2000
- Decision date
- April 6, 2000
- 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 Urine Cannabinoids (THC) Screen Flex Reagent Cartridge, Catalog No. DF 95A cleared by the FDA?
Urine Cannabinoids (THC) Screen Flex Reagent Cartridge, Catalog No. DF 95A (K000461) received a 510(k) decision of Substantially Equivalent on April 6, 2000, 55 days after the submission was received.
What is the product code of K000461?
The FDA product code is LDJ – Enzyme Immunoassay, Cannabinoids, a Class II (moderate risk) device regulated under 21 CFR 862.3870.