510(k) K820138
- Device
- Primidone Reagent Test Kit
- Applicant
- BECKMAN INSTRUMENTS, INC.
- 510(k) number
- K820138
- Product code
- DJD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-01-28
- Date received
- 1982-01-18
- Regulation
- 862.3680
- Classification name
- Enzyme Immunoassay, Primidone
- Medical specialty
- Clinical Toxicology
- Review panel
- Clinical 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#
- 2517506
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DJD#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K973582 | ACE PRIMIDONE REAGENT, AED CALIBRATORS | Schiapparelli Biosystems, Inc. | 1997-11-12 |
| K910527 | EMIT CONVENIENCE PACK FOR THE COBAS MIRA PRIMIDONE | Syva Co. | 1991-03-14 |
| K840939 | EMIT QST PRIMIDONE ASSAY | Syva Co. | 1984-04-24 |
| K832798 | MODIFICA-OF EMIT AED PRIMIDONE ASSAY | Syva Co. | 1983-10-14 |
| K813597 | TDX PRIMIDONE | Abbott Laboratories | 1982-01-22 |
| K802654 | AMES TDA PRIMIDONE TEST | Miles Laboratories, Inc. | 1980-11-12 |
| K781957 | ANALYTICAL TEST PACK, PRIMIDONE | E.I. Dupont DE Nemours & Co., Inc. | 1979-01-10 |