Abusign(Tm) THC, Doa-Thc, Accusign(Tm) THC, Doa-Thc, Diosign(Tm) THC, Doa-Thc
FDA 510(k) K945550 · Princeton BioMeditech Corp.
510(k) numberK945550
Submission
- Device name
- Abusign(Tm) THC, Doa-Thc, Accusign(Tm) THC, Doa-Thc, Diosign(Tm) THC, Doa-Thc
- Applicant
- Princeton BioMeditech Corp.
Princeton, NJ, US - Received
- November 14, 1994
- Decision date
- February 22, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 Abusign(Tm) THC, Doa-Thc, Accusign(Tm) THC, Doa-Thc, Diosign(Tm) THC, Doa-Thc cleared by the FDA?
Abusign(Tm) THC, Doa-Thc, Accusign(Tm) THC, Doa-Thc, Diosign(Tm) THC, Doa-Thc (K945550) received a 510(k) decision of Substantially Equivalent on February 22, 1995, 100 days after the submission was received.
What is the product code of K945550?
The FDA product code is LDJ – Enzyme Immunoassay, Cannabinoids, a Class II (moderate risk) device regulated under 21 CFR 862.3870.