Target Cocaine Metabolite-V
FDA 510(k) K910123 · V-Tech, Inc.
510(k) numberK910123
Submission
- Device name
- Target Cocaine Metabolite-V
- Applicant
- V-Tech, Inc.
El Monte, CA, US - Received
- January 11, 1991
- Decision date
- March 19, 1991
- 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 |
| 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 |
| K871549 | Resub. Urine Cocaine Meta. Direct Ria Kit [I-125]KLN · Traditional | Immunalysis Corporation | 06/16/1987SE |
More from Immunalysis Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K914303 | Target(Tm)-HogJHI · Traditional | 10/11/1991SE |
| K910893 | Target(Tm) Cannabinoids-R TestLDJ · Traditional | 04/03/1991SE |
| K910892 | Target(Tm) Cannabinoids-V TestLDJ · Traditional | 04/03/1991SE |
| K910739 | Target Amphetamine/Methamphetamine-R (Reader Meth)DKZ · Traditional | 03/21/1991SE |
| K910738 | Target Amphetamine/Methamphetamine-V (Visual Meth)DKZ · Traditional | 03/19/1991SE |
| K910122 | Target Cocaine Metabolite-RKLN · Traditional | 03/19/1991SE |
| K903937 | Target(Tm) Hog One StepJHI · Traditional | 10/22/1990SE |
| K890978 | Target Opiates-RDJG · Traditional | 11/17/1989SE |
| K890979 | Target Opiates-VDJG · Traditional | 10/04/1989SE |
| K890295 | Target(Tm) Ck-MbJHY · Traditional | 08/15/1989SE |
Questions and answers
When was Target Cocaine Metabolite-V cleared by the FDA?
Target Cocaine Metabolite-V (K910123) received a 510(k) decision of Substantially Equivalent on March 19, 1991, 67 days after the submission was received.
What is the product code of K910123?
The FDA product code is KLN – Radioimmunoassay, Cocaine Metabolite, a Class II (moderate risk) device regulated under 21 CFR 862.3250.