FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LLC-MK2 (MONKEY KIDNEY, MACACA MULATA) CELL CULTURE
K Number: K951440
·
Decision May 22, 1996
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
169
Applicant Total
25
Review Days
420
Basic Information
- Device Name
- LLC-MK2 (MONKEY KIDNEY, MACACA MULATA) CELL CULTURE
- K Number
- K951440
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.2280
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- VIROMED LABORATORIES, INC.
- Date Received
- March 29, 1995
- Decision Date
- May 22, 1996
- 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 |
| K871613 | BUFFALO GREEN MONKEY KIDNEY CELLS | May 13, 1987 | Substantially Equivalent |
| K862555 | HUMAN EPITHELOID CERVIX CARCINOMA CELLS (HELA) | Jul 10, 1986 | 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 |
| K843250 | BHK-21 | Sep 6, 1984 | Substantially Equivalent |
| K843251 | RD CELLS | Sep 6, 1984 | Substantially Equivalent |