Panels › Hematology › Product code KIR · Class 1
Cells, Animal And Human, Cultured
Regulation 864.2280
0510(k)s in 12 months (170 all time)
0recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in KIR
| Company | 510(k)s | Recalls |
|---|---|---|
| Proteins Intl., Inc. | 51 | 0 |
| Viromed Laboratories, Inc. | 22 | 0 |
| Advanced Clinical Diagnostics | 18 | 0 |
| Earl-Clay Laboratories, Inc. | 17 | 0 |
| Neogenex | 15 | 0 |
| Diagnostic Hybrids, Inc. | 13 | 1 |
| Bartels Immunodiagnostic Supplies, Inc. | 10 | 0 |
| Genus Diagnostics | 8 | 0 |
| Biocon, Inc. | 3 | 0 |
| Difco Laboratories, Inc. | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 11, 1984 | K841337 | ULTRACLONE ECL-01-800 CELL LINE Earl-Clay Laboratories, Inc. | KIR |
| May 7, 1984 | K841666 | RABBIT KIDNEY CELLS Viromed Laboratories, Inc. | KIR |
| May 7, 1984 | K841665 | RHESUS SV5/SV40 Viromed Laboratories, Inc. | KIR |
| Mar 22, 1984 | K834126 | MRC-5 CELLS Bartels Immunodiagnostic Supplies, Inc. | KIR |
| Mar 22, 1984 | K834124 | VERO CELLS Bartels Immunodiagnostic Supplies, Inc. | KIR |
| Mar 22, 1984 | K834123 | WI-38 HUMAN LUNG CELLS Bartels Immunodiagnostic Supplies, Inc. | KIR |
| Mar 22, 1984 | K834120 | LLC-MK2-RHESUS MONKEY KIDNEY CELLS Bartels Immunodiagnostic Supplies, Inc. | KIR |
| Mar 22, 1984 | K834119 | MCCOY CELLS Bartels Immunodiagnostic Supplies, Inc. | KIR |
| Mar 22, 1984 | K834117 | HUMAN FIBROBLASTIC CELLS-HUMAN NEWBORN Bartels Immunodiagnostic Supplies, Inc. | KIR |
| Nov 3, 1983 | K833360 | HEP-2 CELLS Biocon, Inc. | KIR |
| Nov 3, 1983 | K833359 | WI-38 CELLS Biocon, Inc. | KIR |
| Nov 3, 1983 | K833358 | MRC-5 CELLS Biocon, Inc. | KIR |
| Sep 29, 1983 | K832947 | ORTHO CELL CULTURES-MRC-5 HUMAN EMBRYO Ortho Diagnostic Systems, Inc. | KIR |
| Jul 6, 1983 | K831684 | CYNOMOLGUS MONKEY KIDNEY CELLS SV5 Viromed Laboratories, Inc. | KIR |
| Jul 6, 1983 | K831683 | SF CELLS Viromed Laboratories, Inc. | KIR |
| Jul 6, 1983 | K831682 | MCCOY CELLS Viromed Laboratories, Inc. | KIR |
| Jul 6, 1983 | K831681 | HEP-2 CELLS Viromed Laboratories, Inc. | KIR |
| Jul 6, 1983 | K831680 | VERO CELLS Viromed Laboratories, Inc. | KIR |
| Jul 6, 1983 | K831679 | MRC-5 CELLS Viromed Laboratories, Inc. | KIR |
| Aug 14, 1978 | K780869 | CELL CULTURE LINES Bioassay Systems Research Corp. | KIR |
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