FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CALCIUM CHLORIDE/DIETHYLBARB ACETATE BUFF SOLUTION
K Number: K924509
·
Decision Dec 21, 1992
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
179
Applicant Total
145
Review Days
108
Basic Information
- Device Name
- CALCIUM CHLORIDE/DIETHYLBARB ACETATE BUFF SOLUTION
- K Number
- K924509
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5425
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- BEHRING DIAGNOSTICS, INC.
- Date Received
- September 4, 1992
- Decision Date
- December 21, 1992
- 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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