FDA 510(k)
FDA class 2
Substantially Equivalent
🇦🇺 Australia
SAMPLOK LUER KIT
K Number: K021941
·
Decision Jul 2, 2002
Classifications
1
FEI Numbers
218
Registration Numbers
218
Same Product Code
235
Applicant Total
5
Review Days
19
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Basic Information
- Device Name
- SAMPLOK LUER KIT
- K Number
- K021941
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 862.1675
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Itl Corporation Pty, Ltd.
- Date Received
- June 13, 2002
- Decision Date
- July 2, 2002
- 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 Itl Corporation Pty, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K153472 | Quiver Laparoscopic Extendable | Jun 23, 2016 | Substantially Equivalent |
| K021017 | LEESPEC DISPOSABLE VAGINAL SPECULUM | Jun 19, 2002 | Substantially Equivalent |
| K000777 | SAMPLOK | Apr 11, 2000 | Substantially Equivalent |
| K991404 | PLATYPUS AV FISTULA NEEDLE PROTECTOR (AVFNP) | May 14, 1999 | Substantially Equivalent |