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 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K973209 | FRESH CELLS VERO | Diagnostic Hybrids, Inc. | 1997-09-25 | Traditional | PDF ↗ |
| K973210 | FRESH CELLS NCI H292 | Diagnostic Hybrids, Inc. | 1997-09-25 | Traditional | PDF ↗ |
| K973211 | FRESH CELLS MV1LU | Diagnostic Hybrids, Inc. | 1997-09-25 | Traditional | PDF ↗ |
| K973214 | FRESH CELLS HFF | Diagnostic Hybrids, Inc. | 1997-09-25 | Traditional | PDF ↗ |
| K973213 | FRESH CELLS LLC-MK2 | Diagnostic Hybrids, Inc. | 1997-09-25 | Traditional | PDF ↗ |
| K973212 | FRESH CELLS WI-38 | Diagnostic Hybrids, Inc. | 1997-09-25 | Traditional | PDF ↗ |
| K971508 | RHMK II CELL CULTURE, AN EXPANDED PRIMARY RHESUS MONKEY KIDNEY CELL CULTURE | Bio-Whittaker, Inc., A Cambrex Co. | 1997-09-17 | Traditional | PDF ↗ |
| K972414 | FRESHCELLS | Diagnostic Hybrids, Inc. | 1997-08-29 | Traditional | PDF ↗ |
| K965047 | MINK LUNG CELL CULTURE | Neogenex | 1997-02-04 | Traditional | PDF ↗ |
| K962306 | FRESH CELLS MULTI-WELL & SHELL VIAL CULTURES | Diagnostic Hybrids, Inc. | 1996-08-29 | Traditional | PDF ↗ |
| K962311 | FRESHFROZENCELLS | Diagnostic Hybrids, Inc. | 1996-08-29 | Traditional | PDF ↗ |
| K962782 | FRESHFROZEN CELLS, HEP-2 | Diagnostic Hybrids, Inc. | 1996-08-29 | Traditional | PDF ↗ |
| K962780 | FRESHCELLS, HEP-2 | Diagnostic Hybrids, Inc. | 1996-08-29 | Traditional | PDF ↗ |
| K955608 | MCCOY CELL CULTURES | Vai Diagnostics, Inc. | 1996-07-08 | Traditional | PDF ↗ |
| K960909 | H292 CELL CULTURE | Neogenex | 1996-05-30 | Traditional | PDF ↗ |
| K951461 | NCI-H292 CELL CULTURE | Viromed Laboratories, Inc. | 1996-05-22 | Traditional | PDF ↗ |
| K951440 | LLC-MK2 (MONKEY KIDNEY, MACACA MULATA) CELL CULTURE | Viromed Laboratories, Inc. | 1996-05-22 | Traditional | PDF ↗ |
| K955921 | A549 CELL CULTURE | Viratest Intl., Inc. | 1996-02-16 | Traditional | PDF ↗ |
| K952727 | MRC-5 CELL CULTURE VIAL | Viratest Intl., Inc. | 1995-11-20 | Traditional | PDF ↗ |
| K942820 | H292 | Bartels, Inc. | 1995-05-05 | Traditional | PDF ↗ |
| K943885 | PRIMARY RABBIT KIDNEY CELL CULTURE | Neogenex | 1994-11-28 | Traditional | PDF ↗ |
| K943891 | RD CULTURE CELL | Neogenex | 1994-11-28 | Traditional | PDF ↗ |
| K943888 | MDCK CELL CULTURE | Neogenex | 1994-11-28 | Traditional | PDF ↗ |
| K943884 | PRIMARY MONKEY KIDNEY CELL CULTURE | Neogenex | 1994-11-28 | Traditional | PDF ↗ |
| K943889 | VERO CELL CULTURE | Neogenex | 1994-11-28 | Traditional | PDF ↗ |
| K943890 | WI38 CELL CULTURE | Neogenex | 1994-11-28 | Traditional | PDF ↗ |
| K943886 | BGM CELL CULTURE | Neogenex | 1994-11-28 | Traditional | PDF ↗ |
| K943887 | HUMAN NEWBORN FORESKIN CELL CULTURE | Neogenex | 1994-11-28 | Traditional | PDF ↗ |
| K936271 | FRESH CELLS MULTI-WELL PLATE CULTURES AND SHELL VIAL CULTURE | Diagnostic Hybrids, Inc. | 1994-08-26 | Traditional | PDF ↗ |
| K940502 | FRESH FROZEN CELLS | Diagnostic Hybrids, Inc. | 1994-06-16 | Traditional | PDF ↗ |
| K933927 | HEP-2 CULTURE CELL | Neogenex | 1994-03-31 | Traditional | PDF ↗ |
| K933926 | LLCMK2 CULTURE CELLS | Neogenex | 1994-03-29 | Traditional | PDF ↗ |
| K933924 | MCCOY CULTURE CELL | Neogenex | 1994-03-29 | Traditional | PDF ↗ |
| K933923 | A549 CULTURE CELL | Neogenex | 1994-03-29 | Traditional | PDF ↗ |
| K933925 | MRC-5 CULTURE CELL | Neogenex | 1994-03-29 | Traditional | PDF ↗ |
| K936169 | RHESUS MONKEY KIDNEY CELLS | Advanced Clinical Diagnostics | 1994-02-03 | Traditional | PDF ↗ |
| K936172 | RHESUS MONKEY KIDNEY CELLS (LLC-MK2) | Advanced Clinical Diagnostics | 1994-02-03 | Traditional | PDF ↗ |
| K936171 | TRANSFORMED PRIMARY HUMAN EMBRYONAL KIDNEY | Advanced Clinical Diagnostics | 1994-02-03 | Traditional | PDF ↗ |
| K934934 | RABBIT KIDNEY CELLS - R.K.C. | Advanced Clinical Diagnostics | 1994-01-28 | Traditional | PDF ↗ |
| K934973 | HELA-229/HELA CELLS | Advanced Clinical Diagnostics | 1994-01-28 | Traditional | PDF ↗ |
| K935766 | PRIMARY AFRICAN GREEN MONKEY KIDNEY CELLS | Advanced Clinical Diagnostics | 1994-01-24 | Traditional | PDF ↗ |
| K935338 | LUNG CACINOMA, HUMAN CELLS | Advanced Clinical Diagnostics | 1994-01-03 | Traditional | PDF ↗ |
| K935336 | CYNOMOLOGUS MONKEY KIDNEY CELLS | Advanced Clinical Diagnostics | 1994-01-03 | Traditional | PDF ↗ |
| K934246 | LUNG DIPLOID HUMAN CELLS-WI-38 | Advanced Clinical Diagnostics | 1994-01-03 | Traditional | PDF ↗ |
| K935339 | HELA HELA EPITHELOID CARCINOMA | Advanced Clinical Diagnostics | 1994-01-03 | Traditional | PDF ↗ |
| K934243 | HUMAN EPIDERMAL CARCINOMA LARYNX CELLS-HEP-2 | Advanced Clinical Diagnostics | 1994-01-03 | Traditional | PDF ↗ |
| K934245 | HUMAN FORESKIN FIBROBLAST CELLS-H.F.F. | Advanced Clinical Diagnostics | 1994-01-03 | Traditional | PDF ↗ |
| K934244 | HUMAN LUNG DIPLOID CELLS-MRC-5 | Advanced Clinical Diagnostics | 1994-01-03 | Traditional | PDF ↗ |
| K934240 | KIDNEY AFRICIAN GREEN MONKEY CELLS-VERO | Advanced Clinical Diagnostics | 1994-01-03 | Traditional | PDF ↗ |
| K934242 | BUFFALO GREEN MONKEY KIDNEY CELLS-B.G.M.K. | Advanced Clinical Diagnostics | 1994-01-03 | Traditional | PDF ↗ |
| K934239 | KIDNEY AFRICAN GREEN MONKEY CELLS-CV-1 | Advanced Clinical Diagnostics | 1994-01-03 | Traditional | PDF ↗ |
| K935337 | RHABDOMYOSARCOMA CELLS | Advanced Clinical Diagnostics | 1994-01-03 | Traditional | PDF ↗ |
| K934241 | MCCOY CULTURE CELLS-MCCOY | Advanced Clinical Diagnostics | 1994-01-03 | Traditional | PDF ↗ |
| K930395 | ONE DRAM SHELL VIAL, CATALOG #02-461 | Proteins Intl., Inc. | 1993-03-24 | Traditional | PDF ↗ |
| K930390 | 25 CM2, 75 CM2, 125 CM2 FLASK, CATALOG #03-291 | Proteins Intl., Inc. | 1993-03-24 | Traditional | PDF ↗ |
| K930396 | 16 X 125 MM TEST TUBE, CATALOG #01-291 | Proteins Intl., Inc. | 1993-03-24 | Traditional | PDF ↗ |
| K930397 | 16 X 125 MM TEST TUBE, CATALOG | Proteins Intl., Inc. | 1993-03-24 | Traditional | PDF ↗ |
| K930393 | ONE DRAM SHELL VIAL, CATALOG #02-261 | Proteins Intl., Inc. | 1993-03-24 | Traditional | PDF ↗ |
| K930392 | 16 X 125 MM TEST TUBE, CATALOG #01-111 | Proteins Intl., Inc. | 1993-03-24 | Traditional | PDF ↗ |
| K930398 | 16 X 125 MM TEST TUBE, CATALOG #01-441 | Proteins Intl., Inc. | 1993-03-24 | Traditional | PDF ↗ |
| K930394 | 25 CM2, 75 CM2, A50 CM2 FLASK, CATALOG #03-211 | Proteins Intl., Inc. | 1993-03-24 | Traditional | PDF ↗ |
| K930391 | 25 CM2, 75 CM2, 150 CM2 FLASK, CATALOG #03-261 | Proteins Intl., Inc. | 1993-03-24 | Traditional | PDF ↗ |
| K930369 | 25CM, 75CM, 150CM, FLASK, CATALOG #03-311 | Proteins Intl., Inc. | 1993-03-23 | Traditional | PDF ↗ |
| K930365 | 25CM2, 75CM2, 150CM2 FLASK, CATALOG #03-241 | Proteins Intl., Inc. | 1993-03-23 | Traditional | PDF ↗ |
| K930377 | 25 CM2, 75 CM2, 150 CM2 FLASK, CATALOG #03-461 | Proteins Intl., Inc. | 1993-03-23 | Traditional | PDF ↗ |
| K930366 | 16 X 25 MM TEST TUBE, CATALOG #01-461 | Proteins Intl., Inc. | 1993-03-23 | Traditional | PDF ↗ |
| K930385 | 16 X 125 MM TEST TUBE, CATALOG #01-421 | Proteins Intl., Inc. | 1993-03-23 | Traditional | PDF ↗ |
| K930374 | 25 CM2, 75 CM2, 150 CM2, FLASK, CATALOG #03-111 | Proteins Intl., Inc. | 1993-03-23 | Traditional | PDF ↗ |
| K930367 | 25CM2. 75CM2, 150 CM, FLASK, CATALOG #03-321 | Proteins Intl., Inc. | 1993-03-23 | Traditional | PDF ↗ |
| K930368 | ONE DRAM SHELL VIAL, CATALOG #02-321 | Proteins Intl., Inc. | 1993-03-23 | Traditional | PDF ↗ |
| K930373 | ONE DRAM SHELL VIAL, CATALOG #02-111 | Proteins Intl., Inc. | 1993-03-23 | Traditional | PDF ↗ |
| K930383 | 25 CM2, 75 CM2, 150 CM2 FLASK, CATALOG #03-421 | Proteins Intl., Inc. | 1993-03-23 | Traditional | PDF ↗ |
| K930372 | 16 X 125 MM TEST TUBE, CATALOG #01-311 | Proteins Intl., Inc. | 1993-03-23 | Traditional | PDF ↗ |
| K930386 | 16 X 125 MM TEST TUBE, CATALOG #01-401 | Proteins Intl., Inc. | 1993-03-23 | Traditional | PDF ↗ |
| K930381 | ONE DRAM SHELL VIAL, CATALOG #02-441 | Proteins Intl., Inc. | 1993-03-23 | Traditional | PDF ↗ |
| K930375 | 16 X 125 MM TEST TUBE, CATALOG #01-211 | Proteins Intl., Inc. | 1993-03-23 | Traditional | PDF ↗ |
| K930382 | ONE DRAMSHELL VIAL, CATALOG #02-421 | Proteins Intl., Inc. | 1993-03-23 | Traditional | PDF ↗ |
| K930389 | ONE DRAM SHELL VIAL, CATALOG #02-291 | Proteins Intl., Inc. | 1993-03-23 | Traditional | PDF ↗ |
| K930388 | 16 X 125 MM TEST TUBE, CATALOG #01-241 | Proteins Intl., Inc. | 1993-03-23 | Traditional | PDF ↗ |
| K930387 | ONE DRAM SHELL VIAL, CATALOG #02-401 | Proteins Intl., Inc. | 1993-03-23 | Traditional | PDF ↗ |
| K930379 | ONE DRAM SHELL VIAL, CATALOG #02-281 | Proteins Intl., Inc. | 1993-03-23 | Traditional | PDF ↗ |
| K930376 | ONE DRAM SHELL VIAL, CATALOG #02-211 | Proteins Intl., Inc. | 1993-03-23 | Traditional | PDF ↗ |
| K930378 | 25 CM2, 75 CM2, 150 CM2 FLASK, CATALOG #03-441 | Proteins Intl., Inc. | 1993-03-23 | Traditional | PDF ↗ |
| K930364 | ONE DRAM SHELL VIAL, CATALOG # 02-241 | Proteins Intl., Inc. | 1993-03-23 | Traditional | PDF ↗ |
| K930325 | CYTOQUANT(TM) MDCK CANINE KIDNEY CELLS | Proteins Intl., Inc. | 1993-03-23 | Traditional | PDF ↗ |
| K930370 | ONE DRAM SHELL VIALS, CATALOG #02-311 | Proteins Intl., Inc. | 1993-03-23 | Traditional | PDF ↗ |
| K930371 | 16 X 125 MM TEST TUBE, CATALOG #01-321 | Proteins Intl., Inc. | 1993-03-23 | Traditional | PDF ↗ |
| K930384 | 25 CM2, 75 CM2, 150 CM2 FLASK, CATALOG #03-401 | Proteins Intl., Inc. | 1993-03-23 | Traditional | PDF ↗ |
| K930380 | 16 X 125 MM TEST TUBE, CATALOG #01-261 | Proteins Intl., Inc. | 1993-03-23 | Traditional | PDF ↗ |
| K924617 | CYTOQUANT HEP-2 CELLS 16 X 125 MM TUBE, #01-251 | Proteins Intl., Inc. | 1992-12-07 | Traditional | PDF ↗ |
| K924621 | CYTOQUANT MRC-5 CELLS, CATALOG #02-101 | Proteins Intl., Inc. | 1992-12-07 | Traditional | PDF ↗ |
| K924618 | CYTOQUANT HEP-2 CELLS 25CM/75CM/175CM FLASK#03-251 | Proteins Intl., Inc. | 1992-12-07 | Traditional | PDF ↗ |
| K924620 | CYTOQUANT MRC-5 CELLS, CATALOG #03-101 | Proteins Intl., Inc. | 1992-12-07 | Traditional | PDF ↗ |
| K924613 | CYTOQUANT MCCOY CELLS 25CM2/75CM2 FLASK/#03-301 | Proteins Intl., Inc. | 1992-12-07 | Traditional | PDF ↗ |
| K924619 | CYTOQUANT MRC-5 CELLS 16 X 125 MM TUBE, #01-101 | Proteins Intl., Inc. | 1992-12-07 | Traditional | PDF ↗ |
| K924612 | CYTOQUANT MCCOY CELLS/ONE DRAM SHELL VIAL #02-301 | Proteins Intl., Inc. | 1992-12-07 | Traditional | PDF ↗ |
| K924615 | CYTOQUANT H292 CELLS 25CM2/75CM2/175CM2 FLASK | Proteins Intl., Inc. | 1992-12-07 | Traditional | PDF ↗ |
| K924623 | CYTOQUANT A-549 CELLS, CATALOG #03-201 | Proteins Intl., Inc. | 1992-12-07 | Traditional | PDF ↗ |
| K924614 | CYTOQUANT H292 HUMAN PULM MUCOEPIDER CARCIN CELLS | Proteins Intl., Inc. | 1992-12-07 | Traditional | PDF ↗ |
| K924616 | CYTOQUANT HEP-2 CELLS, CATALOG #02-251 | Proteins Intl., Inc. | 1992-12-07 | Traditional | PDF ↗ |
Product code KIR · Class I · Hematology. Data: openFDA.