Hycor Accupinch THC Test
FDA 510(k) K901334 · Hycor Biomedical, Inc.
510(k) numberK901334
Submission
- Device name
- Hycor Accupinch THC Test
- Applicant
- Hycor Biomedical, Inc.
Garden Grove, CA, US - Received
- March 22, 1990
- Decision date
- May 14, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 Hycor Accupinch THC Test cleared by the FDA?
Hycor Accupinch THC Test (K901334) received a 510(k) decision of Substantially Equivalent on May 14, 1990, 53 days after the submission was received.
What is the product code of K901334?
The FDA product code is LDJ – Enzyme Immunoassay, Cannabinoids, a Class II (moderate risk) device regulated under 21 CFR 862.3870.