FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SPECTRASCAN
K Number: K781103
·
Decision Sep 27, 1978
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
1
Applicant Total
8
Review Days
86
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Basic Information
- Device Name
- SPECTRASCAN
- K Number
- K781103
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7340
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Medishield, Inc.
- Date Received
- July 3, 1978
- Decision Date
- September 27, 1978
- Product Code
- DAT
- Advisory Committee
- Hematology
- 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 |
|---|---|---|---|
| DAT | Fibrinogen And Split Products, Peroxidase, Antigen, Antiserum, Control | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DAT), ordered by most recent decision date.
View allOther Clearances by Medishield, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K780645 | HMD-2000 BATTERY-POWERED MINI-DRILL, THE | May 3, 1978 | Substantially Equivalent |
| K780646 | AIR-PWOERED COLDRILL | Apr 28, 1978 | Substantially Equivalent |
| K780202 | MONOMER EVACUATION SYSTEM | Feb 21, 1978 | Substantially Equivalent |
| K770161 | MICROFENESTRATED HIP REPLACEMENT COMPON. | Jan 26, 1977 | Substantially Equivalent |
| K761020 | ANKLE (FREEMAN-SWANSON) | Nov 23, 1976 | Substantially Equivalent |
| K761021 | ANKLE INSTRUMENTS (FREEMAN-SWANSON) | Nov 23, 1976 | Substantially Equivalent |
| K760668 | SELECTATEC SYSTEM | Sep 27, 1976 | Substantially Equivalent |