FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ABBOTT SPECTRUM(R) CALCIUM REAGENT
K Number: K894407
·
Decision Sep 25, 1989
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
98
Applicant Total
883
Review Days
70
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Basic Information
- Device Name
- ABBOTT SPECTRUM(R) CALCIUM REAGENT
- K Number
- K894407
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1145
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Abbott Laboratories
- Date Received
- July 17, 1989
- Decision Date
- September 25, 1989
- 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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