FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PROPANE, HIGH PURITY, INSTRUMENT GRADE
K Number: K770393
·
Decision Apr 26, 1977
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
21
Applicant Total
22
Review Days
57
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Basic Information
- Device Name
- PROPANE, HIGH PURITY, INSTRUMENT GRADE
- K Number
- K770393
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2540
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Hycel, Inc.
- Date Received
- February 28, 1977
- Decision Date
- April 26, 1977
- Product Code
- JJO
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| JJO | Flame Emission Photometer For Clinical Use | FDA class 1 | Clinical Chemistry |
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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 |
| K782100 | HYCEL COUNTER 333 | Jan 3, 1979 | Substantially Equivalent |
| K782101 | HYCEL COUNTER 222 | 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 |