FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
EXEC-WASH SOLID PHASE WASHING SYSTEM
K Number: K896631
·
Decision Apr 3, 1990
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
139
Applicant Total
2
Review Days
132
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Basic Information
- Device Name
- EXEC-WASH SOLID PHASE WASHING SYSTEM
- K Number
- K896631
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2750
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Source Scientific Systems, Inc.
- Date Received
- November 22, 1989
- Decision Date
- April 3, 1990
- 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 |
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Other Clearances by Source Scientific Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K901542 | E/LUMINA(TM)/ALLEGRO LITE(TM) LUMINESCENCE MEASURE | Apr 26, 1990 | Substantially Equivalent |