FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CASCADE 480(TM) AUTO COAG ANALYZER, MODIFICATION
K Number: K914946
·
Decision Jan 13, 1992
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
48
Applicant Total
280
Review Days
76
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Basic Information
- Device Name
- CASCADE 480(TM) AUTO COAG ANALYZER, MODIFICATION
- K Number
- K914946
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5400
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Helena Laboratories
- Date Received
- October 29, 1991
- Decision Date
- January 13, 1992
- Product Code
- GKP
- 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 |
|---|---|---|---|
| GKP | Instrument, Coagulation, Automated | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GKP), ordered by most recent decision date.
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ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS; ACL TOP 550 CTS; ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS
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ACL TOP 700 LAS
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ACL TOP (WITH SYSTEM SOFTWARE V3.0.0)
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