FDA 510(k)
FDA class 1
Substantially Equivalent
🇬🇧 United Kingdom
SOURCERER
K Number: K894902
·
Decision Oct 17, 1989
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
62
Applicant Total
8
Review Days
77
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Basic Information
- Device Name
- SOURCERER
- K Number
- K894902
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2320
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Oakfield Instruments, Ltd.
- Date Received
- August 1, 1989
- Decision Date
- October 17, 1989
- Product Code
- JJJ
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- TX
- 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 |
|---|---|---|---|
| JJJ | Counter (Beta, Gamma) For Clinical Use | FDA class 1 | Clinical Chemistry |
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Other Clearances by Oakfield Instruments, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K964804 | FLEXILOG LS | Aug 6, 1997 | Substantially Equivalent |
| K964589 | FLEXILOG 3000 | Mar 4, 1997 | Substantially Equivalent |
| K961895 | FLEXILOG LS 13921 | Nov 4, 1996 | Substantially Equivalent |
| K945069 | FLEXILOG 2000 | Jun 13, 1995 | Substantially Equivalent |
| K920115 | MEDISCINT | Mar 30, 1992 | Substantially Equivalent |
| K902460 | CARDIOSCINT (LEFT VENTRICULAR FUNCTION MONITOR) | Aug 28, 1990 | Substantially Equivalent |
| K896288 | FLEXILOG 1010 AMBULATORY PH MONITORING SYSTEM | May 4, 1990 | Substantially Equivalent |