FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COUNTER 700 & HC-700 HEMO 0 REF.
K Number: K771107
·
Decision Jul 11, 1977
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
129
Applicant Total
22
Review Days
21
Basic Information
- Device Name
- COUNTER 700 & HC-700 HEMO 0 REF.
- K Number
- K771107
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5200
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- HYCEL, INC.
- Date Received
- June 20, 1977
- Decision Date
- July 11, 1977
- Product Code
- GKL
- 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 |
|---|---|---|---|
| GKL | Counter, Cell, Automated (Particle Counter) | FDA class 2 | Hematology |
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Other Clearances by HYCEL, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K802422 | HYCEL TRIGYCERIDE II TEST | Oct 6, 1980 | Unknown |
| K790335 | HYCEL M | Feb 27, 1979 | Substantially Equivalent |
| K782116 | KETOSTEROID TEST, HYCEL-17 | Jan 26, 1979 | Substantially Equivalent |
| K782176 | HYCEL LDH-INT TEST | Jan 26, 1979 | Substantially Equivalent |
| K782102 | HYCEL COUNTER 211 | Jan 3, 1979 | Substantially Equivalent |
| K782101 | HYCEL COUNTER 222 | Jan 3, 1979 | Substantially Equivalent |
| K782100 | HYCEL COUNTER 333 | Jan 3, 1979 | Substantially Equivalent |
| K781004 | HMA URIC ACID TEST | Jul 27, 1978 | Substantially Equivalent |
| K780946 | ROYCO MODEL 970 HEMATOLOGY DATA ANALYZER | Jul 27, 1978 | Substantially Equivalent |
| K780464 | LELECTIVE KINETIC SYSTEM-60 | May 3, 1978 | Substantially Equivalent |