FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DU PONT IDENTIFICATION CAMERA
K Number: K910354
·
Decision Mar 29, 1991
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
17
Applicant Total
28
Review Days
59
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Basic Information
- Device Name
- DU PONT IDENTIFICATION CAMERA
- K Number
- K910354
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1640
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Dupont Medical Products
- Date Received
- January 29, 1991
- Decision Date
- March 29, 1991
- Product Code
- JAC
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| JAC | System, X-Ray, Film Marking, Radiographic | FDA class 1 | Radiology |
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Other Clearances by Dupont Medical Products
| K Number | Device Name | ||
|---|---|---|---|
| K952815 | DUPONT LIPASE CALIBRATOR | Aug 31, 1995 | Substantially Equivalent |
| K950920 | DUPONT DIMENSION TOTAL PROTEIN METHOD | Aug 11, 1995 | Substantially Equivalent |
| K952816 | LIPASE FLEX REAGENT CARTRIDGE | Jul 20, 1995 | Substantially Equivalent |
| K952412 | DUPONT ACA(R) URINE DRUGE OS ABUSE CONTROL | Jun 23, 1995 | Substantially Equivalent |
| K945280 | DUPONT DIMENSION C-REACTIVE PROTEIN METHOD | Mar 9, 1995 | Substantially Equivalent |
| K944932 | PHENOBARBITAL FLEX REAGENT CARTRIDGE | Dec 28, 1994 | Substantially Equivalent |
| K941050 | DUPONT ACA STAR | Nov 10, 1994 | Substantially Equivalent |
| K943996 | DUPONT ACA PLUS LUTEINIZING HORMONE (LH) METHOD | Oct 20, 1994 | Substantially Equivalent |
| K941146 | DUPONT ACA PLUS THYROID STIMULATING HORMONE SYSTEM | Oct 3, 1994 | Substantially Equivalent |
| K942640 | DUPONT DIMENSION AMYLASE METHOD | Sep 9, 1994 | Substantially Equivalent |