Urine Cocaine Metabolite Direct Ria Kit (I-125)
FDA 510(k) K913867 · Immunalysis Corporation
510(k) numberK913867
Submission
- Device name
- Urine Cocaine Metabolite Direct Ria Kit (I-125)
- Applicant
- Immunalysis Corporation
Glendale, CA, US - Received
- August 27, 1991
- Decision date
- September 19, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| 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 |
| K871549 | Resub. Urine Cocaine Meta. Direct Ria Kit [I-125]KLN · Traditional | Immunalysis Corporation | 06/16/1987SE |
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Questions and answers
When was Urine Cocaine Metabolite Direct Ria Kit (I-125) cleared by the FDA?
Urine Cocaine Metabolite Direct Ria Kit (I-125) (K913867) received a 510(k) decision of Substantially Equivalent on September 19, 1991, 23 days after the submission was received.
What is the product code of K913867?
The FDA product code is KLN – Radioimmunoassay, Cocaine Metabolite, a Class II (moderate risk) device regulated under 21 CFR 862.3250.