Him Test Cocaine
FDA 510(k) K792429 · Tecknam, Inc.
510(k) numberK792429
Submission
- Device name
- Him Test Cocaine
- Applicant
- Tecknam, Inc.
Mchenry, IL, US - Received
- November 28, 1979
- Decision date
- December 7, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DLN – Hemagglutination, Cocaine Metabolites (Benzoylecgnonine)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3250
- Specialty
- Clinical Toxicology
Other 510(k)s with product code DLN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K950134 | Urine Cocaine Metabolite Screen Flex(Tm) Reagent CatridgeDLN · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 03/21/1995SE |
| K924113 | Abuscreen Online for Cocaine MetaboliteDLN · Traditional | Roche Diagnostic Systems, Inc. | 12/28/1992SE |
| K760401 | Cocaine Kit, Toxi-PakDLN · Traditional | J.T. Baker Chemical Co. | 08/26/1976SE |
Questions and answers
When was Him Test Cocaine cleared by the FDA?
Him Test Cocaine (K792429) received a 510(k) decision of Substantially Equivalent on December 7, 1979, 9 days after the submission was received.
What is the product code of K792429?
The FDA product code is DLN – Hemagglutination, Cocaine Metabolites (Benzoylecgnonine), a Class II (moderate risk) device regulated under 21 CFR 862.3250.