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 |
|---|---|---|---|
| Dec 7, 1992 | K924614 | CYTOQUANT H292 HUMAN PULM MUCOEPIDER CARCIN CELLS Proteins Intl., Inc. | KIR |
| Dec 7, 1992 | K924613 | CYTOQUANT MCCOY CELLS 25CM2/75CM2 FLASK/#03-301 Proteins Intl., Inc. | KIR |
| Dec 7, 1992 | K924612 | CYTOQUANT MCCOY CELLS/ONE DRAM SHELL VIAL #02-301 Proteins Intl., Inc. | KIR |
| Dec 7, 1992 | K924595 | CYTOQUANT HNFS CELLS Proteins Intl., Inc. | KIR |
| Sep 24, 1990 | K902726 | BARTELS EXTRACELLULAR MATRIX Baxter Healthcare Corp | KIR |
| Feb 1, 1990 | K896846 | MADIN-DARBY CANINE KIDNEY CULTURE CELLS Baxter Healthcare Corp | KIR |
| May 13, 1987 | K871613 | BUFFALO GREEN MONKEY KIDNEY CELLS Viromed Laboratories, Inc. | KIR |
| Mar 31, 1987 | K871033 | RABBIT KIDNEY CULTURE CELLS (FIRST PASS) Microscan Div. Baxter Healthcare Corp. | KIR |
| Dec 31, 1986 | K864776 | A549 (HUMAN LUNG CARCINOMA) CULTURE CELLS Bartels Immunodiagnostic Supplies, Inc. | KIR |
| Jul 10, 1986 | K862555 | HUMAN EPITHELOID CERVIX CARCINOMA CELLS (HELA) Viromed Laboratories, Inc. | KIR |
| May 13, 1986 | K861585 | ULTRACLONE 01-2300 CELL LINE Earl-Clay Laboratories, Inc. | KIR |
| May 5, 1986 | K861569 | ULTRACLONE 01-700 CELL LINE Earl-Clay Laboratories, Inc. | KIR |
| Apr 18, 1986 | K861373 | HUMAN LUNG CARCINOMA CELLS (A549) Viromed Laboratories, Inc. | KIR |
| Feb 5, 1986 | K860293 | CELLMATIC CHLAMYDIA CULTURE CONFIRM-MCCOY CELLS Difco Laboratories, Inc. | KIR |
| Feb 5, 1986 | K860292 | CELLMATIC CHLAMYDIA CULTURE CONFIRM-DIFCO-1000 Difco Laboratories, Inc. | KIR |
| Aug 12, 1985 | K853203 | ULTRACLONE ECL-01-2200 CELL LINE Earl-Clay Laboratories, Inc. | KIR |
| Jul 12, 1985 | K852396 | HEK Viromed Laboratories, Inc. | KIR |
| Jul 12, 1985 | K852395 | MINK LUNG Viromed Laboratories, Inc. | KIR |
| Jul 12, 1985 | K852394 | MDCK Viromed Laboratories, Inc. | KIR |
| Jun 4, 1985 | K852206 | HEP-2 GENCELLS Genus Diagnostics | KIR |
| Jun 4, 1985 | K852205 | RMK GENCELLS CULTURE SYSTEM Genus Diagnostics | KIR |
| Jun 4, 1985 | K852204 | MCCOY GENCELLS Genus Diagnostics | KIR |
| May 20, 1985 | K851928 | HEK GENCELLS Genus Diagnostics | KIR |
| May 20, 1985 | K851927 | VERO GENCELLS Genus Diagnostics | KIR |
| May 10, 1985 | K851563 | RK GENCELLS Genus Diagnostics | KIR |
| May 10, 1985 | K851562 | MRC-5 GENCELLS Genus Diagnostics | KIR |
| May 10, 1985 | K851561 | WI-38 GENCELLS Genus Diagnostics | KIR |
| May 10, 1985 | K851545 | ULTRACLONE ECL-01-800 CELL LINE Earl-Clay Laboratories, Inc. | KIR |
| Jan 8, 1985 | K840366 | CELL-MATICS HERPES SIMPLEX VIRUS DETECT Difco Laboratories, Inc. | KIR |
| Oct 31, 1984 | K843579 | ULTRACLONE ECL-01-1100 Earl-Clay Laboratories, Inc. | KIR |
| Oct 31, 1984 | K843578 | ULTRACLONE ECL-01-2100 CELL LINE Earl-Clay Laboratories, Inc. | KIR |
| Oct 31, 1984 | K843577 | ULTRAXLONE ECL-01-1000 CELL LINE Earl-Clay Laboratories, Inc. | KIR |
| Sep 6, 1984 | K843252 | AFRICAN GREEN SV 5/SV 40 Viromed Laboratories, Inc. | KIR |
| Sep 6, 1984 | K843251 | RD CELLS Viromed Laboratories, Inc. | KIR |
| Sep 6, 1984 | K843250 | BHK-21 Viromed Laboratories, Inc. | KIR |
| Jul 27, 1984 | K842584 | HEK Viromed Laboratories, Inc. | KIR |
| Jul 27, 1984 | K842583 | SIRC Viromed Laboratories, Inc. | KIR |
| Jun 27, 1984 | K841998 | IMR-90-DIPLOID-HUMAN FETAL LUNG CELL Bartels Immunodiagnostic Supplies, Inc. | KIR |
| Jun 22, 1984 | K842000 | PRIMARY RABBITT KIDNEY CELL CULTURE Bartels Immunodiagnostic Supplies, Inc. | KIR |
| Jun 22, 1984 | K841999 | BGM CELL CULTURE AFRICAN GREEN MONKEY Bartels Immunodiagnostic Supplies, Inc. | KIR |
| Jun 7, 1984 | K841806 | WI-38 Viromed Laboratories, Inc. | KIR |
| May 11, 1984 | K841346 | ULTRACLONE ECL-01-200 CELL LINE Earl-Clay Laboratories, Inc. | KIR |
| May 11, 1984 | K841345 | ULTRACLONE ECL-01-500 CELL LINE Earl-Clay Laboratories, Inc. | KIR |
| May 11, 1984 | K841344 | ULTRACLONE ECL-01-300 CELL LINE Earl-Clay Laboratories, Inc. | KIR |
| May 11, 1984 | K841343 | ULTRACLONE ECL-01-100 CELL LINE Earl-Clay Laboratories, Inc. | KIR |
| May 11, 1984 | K841342 | ULTRACLONE ECL-01-400 CELL LINE Earl-Clay Laboratories, Inc. | KIR |
| May 11, 1984 | K841341 | ULTRACLONE ECL-01-1000 CELL LINE Earl-Clay Laboratories, Inc. | KIR |
| May 11, 1984 | K841340 | ULTRACLONE ECL-01-900 CELL LINE Earl-Clay Laboratories, Inc. | KIR |
| May 11, 1984 | K841339 | ULTRA CLONE ECL-01-700 CELL LINE Earl-Clay Laboratories, Inc. | KIR |
| May 11, 1984 | K841338 | ULTRACLONE ECL-01-600 CELL LINE Earl-Clay Laboratories, Inc. | KIR |
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