510(k) K760075
- Device
- KIT, METHADONE (TOXI-PAK IMMUNO HI)
- Applicant
- J.T. BAKER CHEMICAL CO.
- 510(k) number
- K760075
- Product code
- DIW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1976-07-20
- Date received
- 1976-06-18
- 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 |
| K801509 | HI-M-TEST FOR METHADONE TEST #2 | Technam, Inc. | 1980-07-14 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases