Product code KIR
- Device name
- Cells, Animal And Human, Cultured
- Medical specialty
- Hematology
- Device class
- 1
- Regulation number
- 864.2280
- Review panel
- PA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K973214 | FRESH CELLS HFF | Diagnostic Hybrids, Inc. | 1997-09-25 |
| K973213 | FRESH CELLS LLC-MK2 | Diagnostic Hybrids, Inc. | 1997-09-25 |
| K973212 | FRESH CELLS WI-38 | Diagnostic Hybrids, Inc. | 1997-09-25 |
| K973211 | FRESH CELLS MV1LU | Diagnostic Hybrids, Inc. | 1997-09-25 |
| K973210 | FRESH CELLS NCI H292 | Diagnostic Hybrids, Inc. | 1997-09-25 |
| K973209 | FRESH CELLS VERO | Diagnostic Hybrids, Inc. | 1997-09-25 |
| K971508 | RHMK II CELL CULTURE, AN EXPANDED PRIMARY RHESUS MONKEY KIDNEY CELL CULTURE | Bio-Whittaker, Inc., A Cambrex Co. | 1997-09-17 |
| K972414 | FRESHCELLS | Diagnostic Hybrids, Inc. | 1997-08-29 |
| K965047 | MINK LUNG CELL CULTURE | Neogenex | 1997-02-04 |
| K962782 | FRESHFROZEN CELLS, HEP-2 | Diagnostic Hybrids, Inc. | 1996-08-29 |
| K962780 | FRESHCELLS, HEP-2 | Diagnostic Hybrids, Inc. | 1996-08-29 |
| K962311 | FRESHFROZENCELLS | Diagnostic Hybrids, Inc. | 1996-08-29 |
| K962306 | FRESH CELLS MULTI-WELL & SHELL VIAL CULTURES | Diagnostic Hybrids, Inc. | 1996-08-29 |
| K955608 | MCCOY CELL CULTURES | Vai Diagnostics, Inc. | 1996-07-08 |
| K960909 | H292 CELL CULTURE | Neogenex | 1996-05-30 |
| K951461 | NCI-H292 CELL CULTURE | Viromed Laboratories, Inc. | 1996-05-22 |
| K951440 | LLC-MK2 (MONKEY KIDNEY, MACACA MULATA) CELL CULTURE | Viromed Laboratories, Inc. | 1996-05-22 |
| K955921 | A549 CELL CULTURE | Viratest Intl., Inc. | 1996-02-16 |
| K952727 | MRC-5 CELL CULTURE VIAL | Viratest Intl., Inc. | 1995-11-20 |
| K942820 | H292 | Bartels, Inc. | 1995-05-05 |
| K943889 | VERO CELL CULTURE | Neogenex | 1994-11-28 |
| K943884 | PRIMARY MONKEY KIDNEY CELL CULTURE | Neogenex | 1994-11-28 |
| K943885 | PRIMARY RABBIT KIDNEY CELL CULTURE | Neogenex | 1994-11-28 |
| K943886 | BGM CELL CULTURE | Neogenex | 1994-11-28 |
| K943888 | MDCK CELL CULTURE | Neogenex | 1994-11-28 |
| K943887 | HUMAN NEWBORN FORESKIN CELL CULTURE | Neogenex | 1994-11-28 |
| K943890 | WI38 CELL CULTURE | Neogenex | 1994-11-28 |
| K943891 | RD CULTURE CELL | Neogenex | 1994-11-28 |
| K936271 | FRESH CELLS MULTI-WELL PLATE CULTURES AND SHELL VIAL CULTURE | Diagnostic Hybrids, Inc. | 1994-08-26 |
| K940502 | FRESH FROZEN CELLS | Diagnostic Hybrids, Inc. | 1994-06-16 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 05700575016899 | PD-L1 Control Slides | AGILENT TECHNOLOGIES, INC. | 2026-04-29 |
| 04015630972524 | HER2 Dual ISH 3-in-1 Xenograft Slides | Ventana Medical Systems, Inc. | 2021-02-03 |
| 04015630971091 | HER2 3-in-1 Xenograft Control Slides | Ventana Medical Systems, Inc. | 2021-01-29 |
| 04015630971909 | HPV FAMILY 6 SYSTEM CONTROL SLIDES [B] | Ventana Medical Systems, Inc. | 2021-01-29 |
| 04015630971961 | HPV 3 in 1 System Control Slides | Ventana Medical Systems, Inc. | 2021-01-29 |
| 05700573001736 | PD-L1 Control Slides | AGILENT TECHNOLOGIES, INC. | 2020-11-17 |
| 05700571112755 | PD-L1 Control Slides | AGILENT TECHNOLOGIES, INC. | 2020-11-17 |
| 30014613339571 | Fresh Cells | DIAGNOSTIC HYBRIDS, INC. | 2020-10-02 |
| 30014613339564 | Fresh Cells | DIAGNOSTIC HYBRIDS, INC. | 2020-09-25 |
| 30014613339281 | Fresh Cells | DIAGNOSTIC HYBRIDS, INC. | 2020-07-14 |
| 30014613339274 | Fresh Cells | DIAGNOSTIC HYBRIDS, INC. | 2020-07-14 |
| B7829500A07 | TdT Control Cell Suspension | Supertechs, Inc. | 2019-10-08 |
| 30014613331698 | Fresh Cells | DIAGNOSTIC HYBRIDS, INC. | 2018-09-21 |
| 30014613331421 | Fresh Cells | DIAGNOSTIC HYBRIDS, INC. | 2018-09-21 |
| 30014613331445 | Fresh Cells | DIAGNOSTIC HYBRIDS, INC. | 2018-09-21 |
| 30014613331438 | Fresh Cells | DIAGNOSTIC HYBRIDS, INC. | 2018-09-21 |
| 30014613331742 | Fresh Cells | DIAGNOSTIC HYBRIDS, INC. | 2018-09-21 |
| 30014613331704 | Fresh Cells | DIAGNOSTIC HYBRIDS, INC. | 2018-09-21 |
| 30014613331711 | Fresh Cells | DIAGNOSTIC HYBRIDS, INC. | 2018-09-21 |
| 30014613331728 | Fresh Cells | DIAGNOSTIC HYBRIDS, INC. | 2018-09-21 |
| 30014613331735 | Fresh Cells | DIAGNOSTIC HYBRIDS, INC. | 2018-09-21 |
| 30014613331414 | Fresh Cells | DIAGNOSTIC HYBRIDS, INC. | 2018-09-21 |
| 30014613331407 | Fresh Cells | DIAGNOSTIC HYBRIDS, INC. | 2018-09-21 |
| 30014613331391 | Fresh Cells | DIAGNOSTIC HYBRIDS, INC. | 2018-09-21 |
| 30014613331384 | Fresh Cells | DIAGNOSTIC HYBRIDS, INC. | 2018-09-21 |
| 30014613331377 | Fresh Cells | DIAGNOSTIC HYBRIDS, INC. | 2018-09-21 |
| 00884999027077 | Vysis | ABBOTT MOLECULAR INC. | 2016-09-10 |
| 00884999027046 | Vysis | ABBOTT MOLECULAR INC. | 2016-09-01 |
| 00884999027015 | Vysis | ABBOTT MOLECULAR INC. | 2016-09-01 |
| 00884999027008 | Vysis | ABBOTT MOLECULAR INC. | 2016-09-01 |