Product code DJP— Clinical Toxicology
ABUSCREEN RADIOIMMUNOASSAY - AMPHETAMINE
- Classification name
- Radioimmunoassay, Amphetamine
- Device class
- Class 2
- Regulation
- 21 CFR 862.3100
- Advisory panel
- Clinical Toxicology
- Total cleared
- 9
- First cleared
- Most recent
Market context for product code DJP
FDA has cleared devices under product code DJP between 1982 and 1996, filed by 5 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.
Clearances per year
- 1996
- 1991
- 1988
- 1985
- 1983
- 1982
Top applicants under product code DJP
Recent clearances under product code DJP
- K960526 — PRIMIDONE EIA TEST
- K913866 — URINE AMPHETAMINE DIRECT RIA KIT (I-125)
- K912755 — ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE
- K882228 — REVISED DOUBLE ANTIBODY AMPHETAMINE
- K881817 — ABUSCREEN(R) ONTRAK(TM) FOR AMPHETAMINES
- K854009 — ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE-HIGH SP
- K830482 — ABUSCREEN RADIOIMMUNOASSAY-AMPHETAMINE
- K823212 — ABUSCREEN RADIOIMMUNOASSAY - AMPHETAMINE
- K812986 — AGGLUTEX AMPHETAMINE TEST KIT
Data sourced from openFDA. This site is unofficial and independent of the FDA.