Coat-A-Count Cocaine Metabolite TKCN1 & TKCN5
FDA 510(k) K870740 · Diagnostic Products Corp.
510(k) numberK870740
Submission
- Device name
- Coat-A-Count Cocaine Metabolite TKCN1 & TKCN5
- Applicant
- Diagnostic Products Corp.
Los Angeles, CA, US - Received
- February 25, 1987
- Decision date
- March 19, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KLN – Radioimmunoassay, Cocaine Metabolite
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3250
- Specialty
- Clinical Toxicology
Other 510(k)s with product code KLN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K010868 | Psychemedics Ria Cocaine AssayKLN · Traditional | Psychemedics Corp. | 11/06/2001SE |
| K913867 | Urine Cocaine Metabolite Direct Ria Kit (I-125)KLN · Traditional | Immunalysis Corporation | 09/19/1991SE |
| K913722 | Abuscreen(R) Radioimmun for Cocaine MetaboliteKLN · Traditional | Roche Diagnostic Systems, Inc. | 09/10/1991SE |
| K912756 | Abuscreen Radioimmunoassay for Cocaine MetaboliteKLN · Traditional | Roche Diagnostic Systems, Inc. | 07/26/1991SE |
| K910123 | Target Cocaine Metabolite-VKLN · Traditional | V-Tech, Inc. | 03/19/1991SE |
| K910122 | Target Cocaine Metabolite-RKLN · Traditional | V-Tech, Inc. | 03/19/1991SE |
| K910044 | Milenia Cocaine MetaboliteKLN · Traditional | Diagnostic Products Corp. | 02/13/1991SE |
| K905730 | Abuscreen Ontrak for Cocaine (200NG/ML)KLN · Traditional | Roche Diagnostic Systems, Inc. | 01/15/1991SE |
| K904995 | Abuscreen Online TM for Cocaine MetaboliteKLN · Traditional | Roche Diagnostic Systems, Inc. | 11/28/1990SE |
| K880674 | Micromedic Crackpot Ria KitKLN · Traditional | Icn Micromedic Systems | 10/06/1988SE |
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Questions and answers
When was Coat-A-Count Cocaine Metabolite TKCN1 & TKCN5 cleared by the FDA?
Coat-A-Count Cocaine Metabolite TKCN1 & TKCN5 (K870740) received a 510(k) decision of Substantially Equivalent on March 19, 1987, 22 days after the submission was received.
What is the product code of K870740?
The FDA product code is KLN – Radioimmunoassay, Cocaine Metabolite, a Class II (moderate risk) device regulated under 21 CFR 862.3250.