510(k) K973582
- Device
- ACE PRIMIDONE REAGENT, AED CALIBRATORS
- Applicant
- SCHIAPPARELLI BIOSYSTEMS, INC.
- 510(k) number
- K973582
- Product code
- DJD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-11-12
- Date received
- 1997-09-22
- Regulation
- 862.3680
- Classification name
- Enzyme Immunoassay, Primidone
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- STEVEN DALESSIO
- Address
- 368 Passaic Ave. Fairfield NJ US 07004 07004
FDA Registration Numbers#
- 2517506
Source Documents#
Other 510(k) Records For Product Code DJD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K820138 | PRIMIDONE REAGENT TEST KIT | Beckman Instruments, Inc. | 1982-01-28 |
| 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 |
Legacy Summary#
summary
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