FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DU PONT DIMENSION PSID CLINICAL CHEMISTRY SYSTEM
K Number: K893775
·
Decision Jul 25, 1989
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
139
Applicant Total
253
Review Days
64
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- DU PONT DIMENSION PSID CLINICAL CHEMISTRY SYSTEM
- K Number
- K893775
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2750
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- E.I. Dupont DE Nemours & Co., Inc.
- Date Received
- May 22, 1989
- Decision Date
- July 25, 1989
- Product Code
- JQW
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JQW | Station, Pipetting And Diluting, For Clinical Use | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JQW), ordered by most recent decision date.
BD VIPER INSTRUMENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
QUATRO SP SAMPLE PROCESSING SYSTEMS (200-499, INCLUSIVE)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
2700 SAMPLE MANAGER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MASTERCAP AM 5.0/MASTERCAP RM 5.0
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MINI SAMPLER PROCESSOR
FDA 510(k)
FDA Class 1
·Clinical Chemistry
GIO. DE VITA E C. S.R.L.(GDV) AUTOMATIC WASHING SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by E.I. Dupont DE Nemours & Co., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K951851 | ALLIANCE CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN DIRECT IMMUNOFLUORESCENCE ASSAY | Jul 24, 1996 | Substantially Equivalent |
| K953725 | CRONEX RADIATION THERAPY VERIFICATION CASSETTE | Sep 6, 1995 | Substantially Equivalent |
| K953724 | CRONEX RADIATION THERAPY CASSETTE | Sep 6, 1995 | Substantially Equivalent |
| K951441 | DUPONT ACA DIGOXIN (DGN A) METHOD | Jun 1, 1995 | Substantially Equivalent |
| K950137 | URINE BARBITURATES SCREEN FLEX(TM) REAGENT CARTRIDGE | Apr 13, 1995 | Substantially Equivalent |
| K950136 | URINE OPIATES SCREEN FLEX(TM) REAGENT CARTRIDGE | Apr 5, 1995 | Substantially Equivalent |
| K950181 | URINE CANNABINOIDS SCREEN FLEX(TM) REAGENT CARTRIDGE | Apr 5, 1995 | Substantially Equivalent |
| K950135 | URINE AMPHETAMINES SCREEN FLEX(TM) REAGENT CARTRIDGE | Mar 30, 1995 | Substantially Equivalent |
| K950182 | URINE METHADONE SCREEN FLEX(TM) REAGENT CARTRIDGE | Mar 21, 1995 | Substantially Equivalent |
| K950134 | URINE COCAINE METABOLITE SCREEN FLEX(TM) REAGENT CATRIDGE | Mar 21, 1995 | Substantially Equivalent |