FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEMOTEMP TM
K Number: K802319
·
Decision Oct 10, 1980
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
3
Applicant Total
38
Review Days
17
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Basic Information
- Device Name
- HEMOTEMP TM
- K Number
- K802319
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.9700
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Marion Laboratories, Inc.
- Date Received
- September 23, 1980
- Decision Date
- October 10, 1980
- Product Code
- KSE
- 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 |
|---|---|---|---|
| KSE | Refrigerator, Freezer, Blood Storage | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KSE), ordered by most recent decision date.
MODIFIED LOW-TEMP. FREEZER MODEL HLT-80LS-85
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·Hematology
SEPCOR TEMPERATURE MONITOR
FDA 510(k)
FDA Class 2
·Hematology
MONITEMP BLOOD PACK TEMP. MONITOR
FDA 510(k)
FDA Class 2
·Hematology
Other Clearances by Marion Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K883391 | POLYMER ADHESIVE BANDAGE | Mar 23, 1989 | Substantially Equivalent for Some Indications |
| K875182 | MODIFIED LABELING FOR TOXI-LAB THC SCREEN | Jul 5, 1988 | Substantially Equivalent |
| K875181 | MODIFIED LABELING FOR TOXI-LAB BROAD SPECTRUM | May 27, 1988 | Substantially Equivalent |
| K874554 | ENVICLUSIVE (TM) | Mar 11, 1988 | Substantially Equivalent |
| K874551 | ENVINET(TM) | Jan 22, 1988 | Substantially Equivalent for Some Indications |
| K874552 | ENVISAN PAD | Jan 22, 1988 | Substantially Equivalent for Some Indications |
| K874553 | ENVISAN PASTE | Dec 18, 1987 | Substantially Equivalent for Some Indications |
| K870864 | CULTURETTE BRAND CDT CLOSTRIDIUM DIFFICILE TEST | Apr 14, 1987 | Substantially Equivalent |
| K863485 | MODIFICATION OF CDT(TM) CLOSTRIDIUM TEST | Sep 17, 1986 | Substantially Equivalent |
| K862123 | BIOSPHERE ANAEROBIC ENVIRONMENTAL DEVICE | Jun 16, 1986 | Substantially Equivalent |