510(k) K822229
- Device
- PRIMIDONE FLUORESCENT IMMUNOASSAY
- Applicant
- AMERICAN DIAGNOSTIC CORP.
- 510(k) number
- K822229
- Product code
- LFT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-08-12
- Date received
- 1982-07-27
- Regulation
- 862.3680
- Classification name
- Fluorescent Immunoassay, Primidone
- 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
FDA Registration Numbers#
- 9610126
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LFT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K950028 | PRIMIDONE FPIA REAGENT SET AND CALIBRATORS | Sigma Diagnostics, Inc. | 1995-03-21 |
| K904683 | STRATUS PRIMIDONE FLUOROMETRIC ENZYME | Baxter Healthcare Corp | 1990-11-28 |
| K895567 | PRIMIDONE (FPIA) KIT | Tudor Laboratories, Inc. | 1989-10-20 |
| K852318 | COBAS FP REAGEN FOR PRIMIDONE & PRIMI CALIBRATORS | Roche Diagnostic Systems, Inc. | 1985-06-25 |
| K842196 | STRATUS PRIMIDONE FLOROMETRIC ENZY | American Dade | 1984-07-11 |
| K823741 | ADVANCE EMIT-AED PRIMEDONE ASSAY | Syva Co. | 1983-01-07 |
| K811007 | AMES TDA TM PRIMIDONE TEST | Miles Laboratories, Inc. | 1981-04-29 |
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