FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SAFETY NEEDLE
K Number: K051019
·
Decision Jul 25, 2005
Classifications
1
FEI Numbers
218
Registration Numbers
218
Same Product Code
235
Applicant Total
6
Review Days
94
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Basic Information
- Device Name
- SAFETY NEEDLE
- K Number
- K051019
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1675
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Sarstedt, Inc.
- Date Received
- April 22, 2005
- Decision Date
- July 25, 2005
- Product Code
- JKA
- 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 |
|---|---|---|---|
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | FDA class 2 | Clinical Chemistry |
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Other Clearances by Sarstedt, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K031359 | S-MONOVETTE EDTA K2-GEL | Sep 12, 2003 | Substantially Equivalent |
| K032150 | SAFETY-MULTIFLY | Sep 12, 2003 | Substantially Equivalent |
| K024237 | URINE MONOVETTE BORIC ACID | Apr 14, 2003 | Substantially Equivalent |
| K003382 | SARSTEDT NEEDLE PROTECTOR | Mar 30, 2001 | Substantially Equivalent |
| K913622 | HEMOPLUS | Jan 31, 1992 | Substantially Equivalent |