Product code DJD— Clinical Toxicology

FDA has cleared 8 devices under product code DJD between 1979 and 1997, filed by 6 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 19971 clearance
• 19911 clearance
• 19841 clearance
• 19831 clearance
• 19822 clearances
• 19801 clearance
• 19791 clearance

• Syva Co.3 clearances
• Schiapparelli Biosystems, Inc.1 clearance
• Miles Laboratories, Inc.1 clearance
• E.I. Dupont DE Nemours & Co., Inc.1 clearance
• Beckman Instruments, Inc.1 clearance
• Abbott Laboratories1 clearance

• K973582 — ACE PRIMIDONE REAGENT, AED CALIBRATORSSchiapparelli Biosystems, Inc.·1997-11-12
• K910527 — EMIT CONVENIENCE PACK FOR THE COBAS MIRA PRIMIDONESyva Co.·1991-03-14
• K840939 — EMIT QST PRIMIDONE ASSAYSyva Co.·1984-04-24
• K832798 — MODIFICA-OF EMIT AED PRIMIDONE ASSAYSyva Co.·1983-10-14
• K820138 — PRIMIDONE REAGENT TEST KITBeckman Instruments, Inc.·1982-01-28
• K813597 — TDX PRIMIDONEAbbott Laboratories·1982-01-22
• K802654 — AMES TDA PRIMIDONE TESTMiles Laboratories, Inc.·1980-11-12
• K781957 — ANALYTICAL TEST PACK, PRIMIDONEE.I. Dupont DE Nemours & Co., Inc.·1979-01-10