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 |
|---|---|---|---|
| Sep 25, 1997 | K973214 | FRESH CELLS HFF Diagnostic Hybrids, Inc. | KIR |
| Sep 25, 1997 | K973213 | FRESH CELLS LLC-MK2 Diagnostic Hybrids, Inc. | KIR |
| Sep 25, 1997 | K973212 | FRESH CELLS WI-38 Diagnostic Hybrids, Inc. | KIR |
| Sep 25, 1997 | K973211 | FRESH CELLS MV1LU Diagnostic Hybrids, Inc. | KIR |
| Sep 25, 1997 | K973210 | FRESH CELLS NCI H292 Diagnostic Hybrids, Inc. | KIR |
| Sep 25, 1997 | K973209 | FRESH CELLS VERO Diagnostic Hybrids, Inc. | KIR |
| Sep 17, 1997 | K971508 | RHMK II CELL CULTURE, AN EXPANDED PRIMARY RHESUS MONKEY KIDNEY CELL CULTURE Bio-Whittaker, Inc., A Cambrex Co. | KIR |
| Aug 29, 1997 | K972414 | FRESHCELLS Diagnostic Hybrids, Inc. | KIR |
| Feb 4, 1997 | K965047 | MINK LUNG CELL CULTURE Neogenex | KIR |
| Aug 29, 1996 | K962782 | FRESHFROZEN CELLS, HEP-2 Diagnostic Hybrids, Inc. | KIR |
| Aug 29, 1996 | K962780 | FRESHCELLS, HEP-2 Diagnostic Hybrids, Inc. | KIR |
| Aug 29, 1996 | K962311 | FRESHFROZENCELLS Diagnostic Hybrids, Inc. | KIR |
| Aug 29, 1996 | K962306 | FRESH CELLS MULTI-WELL & SHELL VIAL CULTURES Diagnostic Hybrids, Inc. | KIR |
| Jul 8, 1996 | K955608 | MCCOY CELL CULTURES Vai Diagnostics, Inc. | KIR |
| May 30, 1996 | K960909 | H292 CELL CULTURE Neogenex | KIR |
| May 22, 1996 | K951461 | NCI-H292 CELL CULTURE Viromed Laboratories, Inc. | KIR |
| May 22, 1996 | K951440 | LLC-MK2 (MONKEY KIDNEY, MACACA MULATA) CELL CULTURE Viromed Laboratories, Inc. | KIR |
| Feb 16, 1996 | K955921 | A549 CELL CULTURE Viratest Intl., Inc. | KIR |
| Nov 20, 1995 | K952727 | MRC-5 CELL CULTURE VIAL Viratest Intl., Inc. | KIR |
| May 5, 1995 | K942820 | H292 Bartels, Inc. | KIR |
| Nov 28, 1994 | K943891 | RD CULTURE CELL Neogenex | KIR |
| Nov 28, 1994 | K943890 | WI38 CELL CULTURE Neogenex | KIR |
| Nov 28, 1994 | K943889 | VERO CELL CULTURE Neogenex | KIR |
| Nov 28, 1994 | K943888 | MDCK CELL CULTURE Neogenex | KIR |
| Nov 28, 1994 | K943887 | HUMAN NEWBORN FORESKIN CELL CULTURE Neogenex | KIR |
| Nov 28, 1994 | K943886 | BGM CELL CULTURE Neogenex | KIR |
| Nov 28, 1994 | K943885 | PRIMARY RABBIT KIDNEY CELL CULTURE Neogenex | KIR |
| Nov 28, 1994 | K943884 | PRIMARY MONKEY KIDNEY CELL CULTURE Neogenex | KIR |
| Aug 26, 1994 | K936271 | FRESH CELLS MULTI-WELL PLATE CULTURES AND SHELL VIAL CULTURE Diagnostic Hybrids, Inc. | KIR |
| Jun 16, 1994 | K940502 | FRESH FROZEN CELLS Diagnostic Hybrids, Inc. | KIR |
| Mar 31, 1994 | K933927 | HEP-2 CULTURE CELL Neogenex | KIR |
| Mar 29, 1994 | K933926 | LLCMK2 CULTURE CELLS Neogenex | KIR |
| Mar 29, 1994 | K933925 | MRC-5 CULTURE CELL Neogenex | KIR |
| Mar 29, 1994 | K933924 | MCCOY CULTURE CELL Neogenex | KIR |
| Mar 29, 1994 | K933923 | A549 CULTURE CELL Neogenex | KIR |
| Feb 3, 1994 | K936172 | RHESUS MONKEY KIDNEY CELLS (LLC-MK2) Advanced Clinical Diagnostics | KIR |
| Feb 3, 1994 | K936171 | TRANSFORMED PRIMARY HUMAN EMBRYONAL KIDNEY Advanced Clinical Diagnostics | KIR |
| Feb 3, 1994 | K936169 | RHESUS MONKEY KIDNEY CELLS Advanced Clinical Diagnostics | KIR |
| Jan 28, 1994 | K934973 | HELA-229/HELA CELLS Advanced Clinical Diagnostics | KIR |
| Jan 28, 1994 | K934934 | RABBIT KIDNEY CELLS - R.K.C. Advanced Clinical Diagnostics | KIR |
| Jan 24, 1994 | K935766 | PRIMARY AFRICAN GREEN MONKEY KIDNEY CELLS Advanced Clinical Diagnostics | KIR |
| Jan 3, 1994 | K935339 | HELA HELA EPITHELOID CARCINOMA Advanced Clinical Diagnostics | KIR |
| Jan 3, 1994 | K935338 | LUNG CACINOMA, HUMAN CELLS Advanced Clinical Diagnostics | KIR |
| Jan 3, 1994 | K935337 | RHABDOMYOSARCOMA CELLS Advanced Clinical Diagnostics | KIR |
| Jan 3, 1994 | K935336 | CYNOMOLOGUS MONKEY KIDNEY CELLS Advanced Clinical Diagnostics | KIR |
| Jan 3, 1994 | K934246 | LUNG DIPLOID HUMAN CELLS-WI-38 Advanced Clinical Diagnostics | KIR |
| Jan 3, 1994 | K934245 | HUMAN FORESKIN FIBROBLAST CELLS-H.F.F. Advanced Clinical Diagnostics | KIR |
| Jan 3, 1994 | K934244 | HUMAN LUNG DIPLOID CELLS-MRC-5 Advanced Clinical Diagnostics | KIR |
| Jan 3, 1994 | K934243 | HUMAN EPIDERMAL CARCINOMA LARYNX CELLS-HEP-2 Advanced Clinical Diagnostics | KIR |
| Jan 3, 1994 | K934242 | BUFFALO GREEN MONKEY KIDNEY CELLS-B.G.M.K. Advanced Clinical Diagnostics | KIR |
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