FDA Product Code
FDA Product Code KIR — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.2280
510(k) Clearances — 170 records · page 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K924624 | CYTOQUANT A-549 CELLS, 16X125 MM TUBE #01-201 | Proteins Intl., Inc. | 1992-12-07 | Traditional | PDF ↗ |
| K924595 | CYTOQUANT HNFS CELLS | Proteins Intl., Inc. | 1992-12-07 | Traditional | PDF ↗ |
| K924622 | CYTOQUANT A-549 CELLS, CATALOG #02-201 | Proteins Intl., Inc. | 1992-12-07 | Traditional | PDF ↗ |
| K924625 | CYTOQUANT HLNFS CELLS, CATLOG #03-151 | Proteins Intl., Inc. | 1992-12-07 | Traditional | PDF ↗ |
| K902726 | BARTELS EXTRACELLULAR MATRIX | Baxter Healthcare Corp | 1990-09-24 | Traditional | PDF ↗ |
| K896846 | MADIN-DARBY CANINE KIDNEY CULTURE CELLS | Baxter Healthcare Corp | 1990-02-01 | Traditional | PDF ↗ |
| K871613 | BUFFALO GREEN MONKEY KIDNEY CELLS | Viromed Laboratories, Inc. | 1987-05-13 | Traditional | PDF ↗ |
| K871033 | RABBIT KIDNEY CULTURE CELLS (FIRST PASS) | Microscan Div. Baxter Healthcare Corp. | 1987-03-31 | Traditional | PDF ↗ |
| K864776 | A549 (HUMAN LUNG CARCINOMA) CULTURE CELLS | Bartels Immunodiagnostic Supplies, Inc. | 1986-12-31 | Traditional | PDF ↗ |
| K862555 | HUMAN EPITHELOID CERVIX CARCINOMA CELLS (HELA) | Viromed Laboratories, Inc. | 1986-07-10 | Traditional | PDF ↗ |
| K861585 | ULTRACLONE 01-2300 CELL LINE | Earl-Clay Laboratories, Inc. | 1986-05-13 | Traditional | PDF ↗ |
| K861569 | ULTRACLONE 01-700 CELL LINE | Earl-Clay Laboratories, Inc. | 1986-05-05 | Traditional | PDF ↗ |
| K861373 | HUMAN LUNG CARCINOMA CELLS (A549) | Viromed Laboratories, Inc. | 1986-04-18 | Traditional | PDF ↗ |
| K860292 | CELLMATIC CHLAMYDIA CULTURE CONFIRM-DIFCO-1000 | Difco Laboratories, Inc. | 1986-02-05 | Traditional | PDF ↗ |
| K860293 | CELLMATIC CHLAMYDIA CULTURE CONFIRM-MCCOY CELLS | Difco Laboratories, Inc. | 1986-02-05 | Traditional | PDF ↗ |
| K853203 | ULTRACLONE ECL-01-2200 CELL LINE | Earl-Clay Laboratories, Inc. | 1985-08-12 | Traditional | PDF ↗ |
| K852396 | HEK | Viromed Laboratories, Inc. | 1985-07-12 | Traditional | PDF ↗ |
| K852394 | MDCK | Viromed Laboratories, Inc. | 1985-07-12 | Traditional | PDF ↗ |
| K852395 | MINK LUNG | Viromed Laboratories, Inc. | 1985-07-12 | Traditional | PDF ↗ |
| K852204 | MCCOY GENCELLS | Genus Diagnostics | 1985-06-04 | Traditional | PDF ↗ |
| K852206 | HEP-2 GENCELLS | Genus Diagnostics | 1985-06-04 | Traditional | PDF ↗ |
| K852205 | RMK GENCELLS CULTURE SYSTEM | Genus Diagnostics | 1985-06-04 | Traditional | PDF ↗ |
| K851928 | HEK GENCELLS | Genus Diagnostics | 1985-05-20 | Traditional | PDF ↗ |
| K851927 | VERO GENCELLS | Genus Diagnostics | 1985-05-20 | Traditional | PDF ↗ |
| K851562 | MRC-5 GENCELLS | Genus Diagnostics | 1985-05-10 | Traditional | PDF ↗ |
| K851563 | RK GENCELLS | Genus Diagnostics | 1985-05-10 | Traditional | PDF ↗ |
| K851561 | WI-38 GENCELLS | Genus Diagnostics | 1985-05-10 | Traditional | PDF ↗ |
| K851545 | ULTRACLONE ECL-01-800 CELL LINE | Earl-Clay Laboratories, Inc. | 1985-05-10 | Traditional | PDF ↗ |
| K840366 | CELL-MATICS HERPES SIMPLEX VIRUS DETECT | Difco Laboratories, Inc. | 1985-01-08 | Traditional | PDF ↗ |
| K843577 | ULTRAXLONE ECL-01-1000 CELL LINE | Earl-Clay Laboratories, Inc. | 1984-10-31 | Traditional | PDF ↗ |
| K843579 | ULTRACLONE ECL-01-1100 | Earl-Clay Laboratories, Inc. | 1984-10-31 | Traditional | PDF ↗ |
| K843578 | ULTRACLONE ECL-01-2100 CELL LINE | Earl-Clay Laboratories, Inc. | 1984-10-31 | Traditional | PDF ↗ |
| K843252 | AFRICAN GREEN SV 5/SV 40 | Viromed Laboratories, Inc. | 1984-09-06 | Traditional | PDF ↗ |
| K843251 | RD CELLS | Viromed Laboratories, Inc. | 1984-09-06 | Traditional | PDF ↗ |
| K843250 | BHK-21 | Viromed Laboratories, Inc. | 1984-09-06 | Traditional | PDF ↗ |
| K842583 | SIRC | Viromed Laboratories, Inc. | 1984-07-27 | Traditional | PDF ↗ |
| K842584 | HEK | Viromed Laboratories, Inc. | 1984-07-27 | Traditional | PDF ↗ |
| K841998 | IMR-90-DIPLOID-HUMAN FETAL LUNG CELL | Bartels Immunodiagnostic Supplies, Inc. | 1984-06-27 | Traditional | PDF ↗ |
| K842000 | PRIMARY RABBITT KIDNEY CELL CULTURE | Bartels Immunodiagnostic Supplies, Inc. | 1984-06-22 | Traditional | PDF ↗ |
| K841999 | BGM CELL CULTURE AFRICAN GREEN MONKEY | Bartels Immunodiagnostic Supplies, Inc. | 1984-06-22 | Traditional | PDF ↗ |
| K841806 | WI-38 | Viromed Laboratories, Inc. | 1984-06-07 | Traditional | PDF ↗ |
| K841339 | ULTRA CLONE ECL-01-700 CELL LINE | Earl-Clay Laboratories, Inc. | 1984-05-11 | Traditional | PDF ↗ |
| K841342 | ULTRACLONE ECL-01-400 CELL LINE | Earl-Clay Laboratories, Inc. | 1984-05-11 | Traditional | PDF ↗ |
| K841341 | ULTRACLONE ECL-01-1000 CELL LINE | Earl-Clay Laboratories, Inc. | 1984-05-11 | Traditional | PDF ↗ |
| K841344 | ULTRACLONE ECL-01-300 CELL LINE | Earl-Clay Laboratories, Inc. | 1984-05-11 | Traditional | PDF ↗ |
| K841343 | ULTRACLONE ECL-01-100 CELL LINE | Earl-Clay Laboratories, Inc. | 1984-05-11 | Traditional | PDF ↗ |
| K841337 | ULTRACLONE ECL-01-800 CELL LINE | Earl-Clay Laboratories, Inc. | 1984-05-11 | Traditional | PDF ↗ |
| K841340 | ULTRACLONE ECL-01-900 CELL LINE | Earl-Clay Laboratories, Inc. | 1984-05-11 | Traditional | PDF ↗ |
| K841345 | ULTRACLONE ECL-01-500 CELL LINE | Earl-Clay Laboratories, Inc. | 1984-05-11 | Traditional | PDF ↗ |
| K841346 | ULTRACLONE ECL-01-200 CELL LINE | Earl-Clay Laboratories, Inc. | 1984-05-11 | Traditional | PDF ↗ |
| K841338 | ULTRACLONE ECL-01-600 CELL LINE | Earl-Clay Laboratories, Inc. | 1984-05-11 | Traditional | PDF ↗ |
| K841665 | RHESUS SV5/SV40 | Viromed Laboratories, Inc. | 1984-05-07 | Traditional | PDF ↗ |
| K841666 | RABBIT KIDNEY CELLS | Viromed Laboratories, Inc. | 1984-05-07 | Traditional | PDF ↗ |
| K834120 | LLC-MK2-RHESUS MONKEY KIDNEY CELLS | Bartels Immunodiagnostic Supplies, Inc. | 1984-03-22 | Traditional | PDF ↗ |
| K834119 | MCCOY CELLS | Bartels Immunodiagnostic Supplies, Inc. | 1984-03-22 | Traditional | PDF ↗ |
| K834123 | WI-38 HUMAN LUNG CELLS | Bartels Immunodiagnostic Supplies, Inc. | 1984-03-22 | Traditional | PDF ↗ |
| K834124 | VERO CELLS | Bartels Immunodiagnostic Supplies, Inc. | 1984-03-22 | Traditional | PDF ↗ |
| K834126 | MRC-5 CELLS | Bartels Immunodiagnostic Supplies, Inc. | 1984-03-22 | Traditional | PDF ↗ |
| K834117 | HUMAN FIBROBLASTIC CELLS-HUMAN NEWBORN | Bartels Immunodiagnostic Supplies, Inc. | 1984-03-22 | Traditional | PDF ↗ |
| K833359 | WI-38 CELLS | Biocon, Inc. | 1983-11-03 | Traditional | PDF ↗ |
| K833360 | HEP-2 CELLS | Biocon, Inc. | 1983-11-03 | Traditional | PDF ↗ |
| K833358 | MRC-5 CELLS | Biocon, Inc. | 1983-11-03 | Traditional | PDF ↗ |
| K832947 | ORTHO CELL CULTURES-MRC-5 HUMAN EMBRYO | Ortho Diagnostic Systems, Inc. | 1983-09-29 | Traditional | PDF ↗ |
| K831679 | MRC-5 CELLS | Viromed Laboratories, Inc. | 1983-07-06 | Traditional | PDF ↗ |
| K831682 | MCCOY CELLS | Viromed Laboratories, Inc. | 1983-07-06 | Traditional | PDF ↗ |
| K831684 | CYNOMOLGUS MONKEY KIDNEY CELLS SV5 | Viromed Laboratories, Inc. | 1983-07-06 | Traditional | PDF ↗ |
| K831680 | VERO CELLS | Viromed Laboratories, Inc. | 1983-07-06 | Traditional | PDF ↗ |
| K831681 | HEP-2 CELLS | Viromed Laboratories, Inc. | 1983-07-06 | Traditional | PDF ↗ |
| K831683 | SF CELLS | Viromed Laboratories, Inc. | 1983-07-06 | Traditional | PDF ↗ |
| K780869 | CELL CULTURE LINES | Bioassay Systems Research Corp. | 1978-08-14 | Traditional | PDF ↗ |
Product code KIR · Class I · Hematology. Data: openFDA.