Crack-It Chap Screen
FDA 510(k) K874389 · Sakers, Inc.
510(k) numberK874389
Submission
- Device name
- Crack-It Chap Screen
- Applicant
- Sakers, Inc.
Westville, NJ, US - Received
- October 27, 1987
- Decision date
- February 7, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DMN – Thin Layer Chromatography, Cocaine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3250
- Specialty
- Clinical Toxicology
Other 510(k)s with product code DMN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K972618 | Quickscreen One Step Cocaine Screening Test (9070)DMN · Traditional | Phamatech | 08/08/1997SE |
More from Phamatech
| 510(k) | Device | Decision |
|---|---|---|
| K874390 | Crack-It Cannabinoid ScreenLDJ · Traditional | 04/10/1989SE |
Questions and answers
When was Crack-It Chap Screen cleared by the FDA?
Crack-It Chap Screen (K874389) received a 510(k) decision of Substantially Equivalent on February 7, 1989, 469 days after the submission was received.
What is the product code of K874389?
The FDA product code is DMN – Thin Layer Chromatography, Cocaine, a Class II (moderate risk) device regulated under 21 CFR 862.3250.