FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CUTTER/COMPUR MINI CENTRIFUGE
K Number: K781059
·
Decision Aug 14, 1978
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
14
Applicant Total
39
Review Days
49
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
- CUTTER/COMPUR MINI CENTRIFUGE
- K Number
- K781059
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5600
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Cutter Laboratories, Inc.
- Date Received
- June 26, 1978
- Decision Date
- August 14, 1978
- Product Code
- GKF
- 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 |
|---|---|---|---|
| GKF | Instrument, Hematocrit, Automated | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GKF), ordered by most recent decision date.
GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation)
FDA 510(k)
FDA Class 2
·Hematology
CRIT-SCAN II MONITOR
FDA 510(k)
FDA Class 2
·Hematology
STAT PROFILE ULTRA F,G,H,I,J,K, AND L ANALYZERS
FDA 510(k)
FDA Class 2
·Hematology
STAT PROFILE ULTRA A, B, C, D, AND E ANALYZERS
FDA 510(k)
FDA Class 2
·Hematology
STAT PROFILE M ANALYZER
FDA 510(k)
FDA Class 2
·Hematology
MICROSPIN 24
FDA 510(k)
FDA Class 2
·Hematology
Other Clearances by Cutter Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K861315 | HYPERBARIC PENETRATION EXTENSION SET | May 21, 1986 | Substantially Equivalent |
| K854106 | BAYSILEX | Mar 17, 1986 | Substantially Equivalent |
| K842324 | PERFOURM | Nov 9, 1984 | Substantially Equivalent |
| K834106 | INTRAVENOUS INFUSION CONTROLLER | May 30, 1984 | Substantially Equivalent |
| K832237 | ORTHOPEDIC CASTING TAPE MAXCAST | Aug 16, 1983 | Substantially Equivalent |
| K823214 | DOSIMETRIC RELEASE PROGRAM - ADMIN. SET | Jan 12, 1983 | Substantially Equivalent |
| K821326 | CUTTER BOND POLYCARBOXYLATE CEMENT | May 28, 1982 | Substantially Equivalent |
| K813532 | CUTTERBOND ZINC PHOSPHATE CEMENT | Mar 2, 1982 | Substantially Equivalent |
| K802105 | C-BLADE | Sep 16, 1980 | Substantially Equivalent |
| K802104 | C-SPLINT | Sep 16, 1980 | Substantially Equivalent |