Product Code: DLN
FDA class 2
21 CFR 862.3250
Hemagglutination, Cocaine Metabolites (Benzoylecgnonine)
Clinical Toxicology
The Hemagglutination test for Cocaine Metabolites (Benzoylecgnonine) is a laboratory immunoassay device that uses red blood cell agglutination principles to detect the primary cocaine metabolite, benzoylecgnonine, in patient urine or other specimens. It is a Class 2 device requiring 510(k) premarket clearance. The product code is DLN, regulated under 21 CFR 862.3250, within the Clinical Toxicology specialty. It is eligible for third-party 510(k) review.
510(k)s
4
FEI Numbers
0
Registration Numbers
0
Unique Applicants
4
Years Active
19
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Basic Information
- Product Code
- DLN
- Device Class
- FDA class 2
- Regulation Number
- 862.3250
- Medical Specialty
- Clinical Toxicology
- Review Panel
- TX
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✓
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K950134 | URINE COCAINE METABOLITE SCREEN FLEX(TM) REAGENT CATRIDGE | Mar 21, 1995 | Substantially Equivalent | E.I. Dupont DE Nemours & Co., Inc. |
| K924113 | ABUSCREEN ONLINE FOR COCAINE METABOLITE | Dec 28, 1992 | Substantially Equivalent | Roche Diagnostic Systems, Inc. |
| K792429 | HIM TEST COCAINE | Dec 07, 1979 | Substantially Equivalent | Tecknam, Inc. |
| K760401 | COCAINE KIT, TOXI-PAK | Aug 26, 1976 | Substantially Equivalent | J.T. Baker Chemical Co. |