510(k) K801509
- Device
- HI-M-TEST FOR METHADONE TEST #2
- Applicant
- TECHNAM, INC.
- 510(k) number
- K801509
- Product code
- DIW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-07-14
- Date received
- 1980-06-30
- Regulation
- 862.3620
- Classification name
- Hemagglutination Inhibition, Methadone
- 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 DIW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K950182 | URINE METHADONE SCREEN FLEX(TM) REAGENT CARTRIDGE | E.I. Dupont DE Nemours & Co., Inc. | 1995-03-21 |
| K930845 | ROCHE ABUSCREEN ONTRAK FOR METHADONE | Roche Diagnostic Systems, Inc. | 1993-04-20 |
| K760075 | KIT, METHADONE (TOXI-PAK IMMUNO HI) | J.T. Baker Chemical Co. | 1976-07-20 |
Legacy Summary#
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FDA Review#
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