510(k) K792429
- Device
- HIM TEST COCAINE
- Applicant
- TECKNAM, INC.
- 510(k) number
- K792429
- Product code
- DLN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1979-12-07
- Date received
- 1979-11-28
- Regulation
- 862.3250
- Classification name
- Hemagglutination, Cocaine Metabolites (benzoylecgnonine)
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DLN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K950134 | URINE COCAINE METABOLITE SCREEN FLEX(TM) REAGENT CATRIDGE | E.I. Dupont DE Nemours & Co., Inc. | 1995-03-21 |
| K924113 | ABUSCREEN ONLINE FOR COCAINE METABOLITE | Roche Diagnostic Systems, Inc. | 1992-12-28 |
| K760401 | COCAINE KIT, TOXI-PAK | J.T. Baker Chemical Co. | 1976-08-26 |
Legacy Summary#
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FDA Review#
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