Crack-It Cannabinoid Screen
FDA 510(k) K874390 · Sakers, Inc.
510(k) numberK874390
Submission
- Device name
- Crack-It Cannabinoid Screen
- Applicant
- Sakers, Inc.
Blackwood, NJ, US - Received
- October 27, 1987
- Decision date
- April 10, 1989
- 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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| K142408 | FaStep Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), FaStep…LDJ · Traditional | Polymed Therapeutics, Inc. | 09/25/2014SE |
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More from Healgen Scientific,, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K874389 | Crack-It Chap ScreenDMN · Traditional | 02/07/1989SE |
Questions and answers
When was Crack-It Cannabinoid Screen cleared by the FDA?
Crack-It Cannabinoid Screen (K874390) received a 510(k) decision of Substantially Equivalent on April 10, 1989, 531 days after the submission was received.
What is the product code of K874390?
The FDA product code is LDJ – Enzyme Immunoassay, Cannabinoids, a Class II (moderate risk) device regulated under 21 CFR 862.3870.