FDA 510(k)
Substantially Equivalent
🇺🇸 United States
CPK-INT TEST
K Number: K771154
·
Decision Jul 21, 1977
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
22
Review Days
23
Basic Information
- Device Name
- CPK-INT TEST
- K Number
- K771154
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- HYCEL, INC.
- Date Received
- June 28, 1977
- Decision Date
- July 21, 1977
- Advisory Committee
- Unknown
- Review Advisory Committee
- CH
- Third Party
- N
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 |