FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
5CM SMALL PARTS SCANNER
K Number: K810914
·
Decision May 8, 1981
Classifications
1
FEI Numbers
348
Registration Numbers
349
Same Product Code
892
Applicant Total
42
Review Days
32
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Basic Information
- Device Name
- 5CM SMALL PARTS SCANNER
- K Number
- K810914
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1560
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Smithkline Diagnostics, Inc.
- Date Received
- April 6, 1981
- Decision Date
- May 8, 1981
- Product Code
- IYO
- 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 |
|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | FDA class 2 | Radiology |
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Other Clearances by Smithkline Diagnostics, Inc.
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|---|---|---|---|
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| K875131 | (SKD) CHOLESTEROL TEST KIT | Mar 1, 1988 | Substantially Equivalent |
| K862849 | HEMOCCULT WIPE TEST | Dec 9, 1986 | Substantially Equivalent |
| K854723 | SKD ELECTROCHEMICAL SYSTEM (ECS) | Mar 5, 1986 | Substantially Equivalent |
| K852841 | RAPID DIRECT STREP A LATEX AGGLUTINATION TEST | Jul 24, 1985 | Substantially Equivalent |
| K821884 | GASTROCCULT TM | Oct 8, 1982 | Substantially Equivalent |
| K821674 | SPINCHEM ACID PHOSPHATASE REAGENT | Jun 22, 1982 | Substantially Equivalent |