FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CAT. NO. 1471 (110V) & CAT. NO. 1472 (220V)
K Number: K921465
·
Decision Jun 29, 1992
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
48
Applicant Total
280
Review Days
94
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Basic Information
- Device Name
- CAT. NO. 1471 (110V) & CAT. NO. 1472 (220V)
- K Number
- K921465
- 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
- March 27, 1992
- Decision Date
- June 29, 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.
ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS)
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ACL TOP Family 70 Series
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ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS)
FDA 510(k)
FDA Class 2
·Hematology
ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS; ACL TOP 550 CTS; ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS
FDA 510(k)
FDA Class 2
·Hematology
ACL TOP 700 LAS
FDA 510(k)
FDA Class 2
·Hematology
ACL TOP (WITH SYSTEM SOFTWARE V3.0.0)
FDA 510(k)
FDA Class 2
·Hematology
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