FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LODE COAGULOMETER MODEL LC-6
K Number: K852450
·
Decision Sep 30, 1985
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
180
Applicant Total
2
Review Days
112
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Basic Information
- Device Name
- LODE COAGULOMETER MODEL LC-6
- K Number
- K852450
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5425
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Lode Corp.
- Date Received
- June 10, 1985
- Decision Date
- September 30, 1985
- Product Code
- JPA
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| JPA | System, Multipurpose For In Vitro Coagulation Studies | FDA class 2 | Hematology |
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Other Clearances by Lode Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K851097 | LODE MODEL CORIVAL ERGOMETER | Jun 18, 1985 | Substantially Equivalent |