FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AVOCET ACUSURE SYSTEM
K Number: K991286
·
Decision Nov 18, 1999
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
126
Applicant Total
4
Review Days
217
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- AVOCET ACUSURE SYSTEM
- K Number
- K991286
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7750
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Avocet Medical, Inc.
- Date Received
- April 15, 1999
- Decision Date
- November 18, 1999
- Product Code
- GJS
- 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 |
|---|---|---|---|
| GJS | Test, Time, Prothrombin | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GJS), ordered by most recent decision date.
CoaguChek XS Plus System
FDA 510(k)
FDA Class 2
·Hematology
microINR System
FDA 510(k)
FDA Class 2
·Hematology
microINR System
FDA 510(k)
FDA Class 2
·Hematology
Xprecia Prime Coagulation System
FDA 510(k)
FDA Class 2
·Hematology
i-STAT PTplus Cartridge with the i-STAT 1 System
FDA 510(k)
FDA Class 2
·Hematology
microINR System
FDA 510(k)
FDA Class 2
·Hematology
Other Clearances by Avocet Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K994006 | AVOCET ACUSURE (FOR PATIENT SELF-TESTING) AND AVOCET ACUSURE PRO (FOR PROFESSIONAL USE) | Feb 3, 2000 | Substantially Equivalent |
| K980839 | AVOCET PT | Sep 30, 1998 | Substantially Equivalent |
| K980982 | AVOCET SYSTEM LIQUID CONTROL LEVEL 1 AND LEVEL 2 | Apr 16, 1998 | Substantially Equivalent |