FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HUMAN EPITHELOID CERVIX CARCINOMA CELLS (HELA)
K Number: K862555
·
Decision Jul 10, 1986
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
169
Applicant Total
25
Review Days
7
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Basic Information
- Device Name
- HUMAN EPITHELOID CERVIX CARCINOMA CELLS (HELA)
- K Number
- K862555
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.2280
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Viromed Laboratories, Inc.
- Date Received
- July 3, 1986
- Decision Date
- July 10, 1986
- Product Code
- KIR
- Advisory Committee
- Hematology
- Review Advisory Committee
- PA
- 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 |
|---|---|---|---|
| KIR | Cells, Animal And Human, Cultured | FDA class 1 | Hematology |
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Other Clearances by Viromed Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K951461 | NCI-H292 CELL CULTURE | May 22, 1996 | Substantially Equivalent |
| K951440 | LLC-MK2 (MONKEY KIDNEY, MACACA MULATA) CELL CULTURE | May 22, 1996 | Substantially Equivalent |
| K871613 | BUFFALO GREEN MONKEY KIDNEY CELLS | May 13, 1987 | Substantially Equivalent |
| K861373 | HUMAN LUNG CARCINOMA CELLS (A549) | Apr 18, 1986 | Substantially Equivalent |
| K853695 | RESPIRATORY SYNCYTIAL VIRUS ID REAGENT | Dec 4, 1985 | Substantially Equivalent |
| K852395 | MINK LUNG | Jul 12, 1985 | Substantially Equivalent |
| K852394 | MDCK | Jul 12, 1985 | Substantially Equivalent |
| K852396 | HEK | Jul 12, 1985 | Substantially Equivalent |
| K843252 | AFRICAN GREEN SV 5/SV 40 | Sep 6, 1984 | Substantially Equivalent |
| K843250 | BHK-21 | Sep 6, 1984 | Substantially Equivalent |