Dbest Tetrahydrocannabinol Test Kit
FDA 510(k) K983188 · Ameritek, Inc.
510(k) numberK983188
Submission
- Device name
- Dbest Tetrahydrocannabinol Test Kit
- Applicant
- Ameritek, Inc.
Seattle, WA, US - Received
- September 11, 1998
- Decision date
- November 18, 1998
- 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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| K983189 | Dbest Methamphetamines Test KitLAF · Traditional | 11/18/1998SE |
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| K974508 | Dbest One-Step Ovulation TestCEP · Traditional | 02/02/1998SE |
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Questions and answers
When was Dbest Tetrahydrocannabinol Test Kit cleared by the FDA?
Dbest Tetrahydrocannabinol Test Kit (K983188) received a 510(k) decision of Substantially Equivalent on November 18, 1998, 68 days after the submission was received.
What is the product code of K983188?
The FDA product code is LDJ – Enzyme Immunoassay, Cannabinoids, a Class II (moderate risk) device regulated under 21 CFR 862.3870.