FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PARAMAX CALCIUM REAGENT
K Number: K873519
·
Decision Dec 14, 1987
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
98
Applicant Total
503
Review Days
104
Basic Information
- Device Name
- PARAMAX CALCIUM REAGENT
- K Number
- K873519
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1145
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- BAXTER HEALTHCARE CORP.
- Date Received
- September 1, 1987
- Decision Date
- December 14, 1987
- Product Code
- CIC
- 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 |
|---|---|---|---|
| CIC | Cresolphthalein Complexone, Calcium | FDA class 2 | Clinical Chemistry |
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