KIR · Cells, Animal And Human, Cultured
Hematology · 21 CFR 864.2280 · Class 1
Overview
| Product Code | KIR |
|---|---|
| Device Name | Cells, Animal And Human, Cultured |
| Regulation | 21 CFR 864.2280 |
| Device Class | Class 1 |
| Review Panel | Hematology |
Identification
Cultured animal and human cells are in vitro cultivated cell lines from the tissue of humans or other animals which are used in various diagnostic procedures, particularly diagnostic virology and cytogenetic studies.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 864.9.
Recent Cleared Devices (20 of 170)
Showing 20 most recent of 170 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K973214 | FRESH CELLS HFF | Diagnostic Hybrids, Inc. | Sep 25, 1997 | SESE |
| K973213 | FRESH CELLS LLC-MK2 | Diagnostic Hybrids, Inc. | Sep 25, 1997 | SESE |
| K973212 | FRESH CELLS WI-38 | Diagnostic Hybrids, Inc. | Sep 25, 1997 | SESE |
| K973211 | FRESH CELLS MV1LU | Diagnostic Hybrids, Inc. | Sep 25, 1997 | SESE |
| K973210 | FRESH CELLS NCI H292 | Diagnostic Hybrids, Inc. | Sep 25, 1997 | SESE |
| K973209 | FRESH CELLS VERO | Diagnostic Hybrids, Inc. | Sep 25, 1997 | SESE |
| K971508 | RHMK II CELL CULTURE, AN EXPANDED PRIMARY RHESUS MONKEY KIDNEY CELL CULTURE | Bio-Whittaker, Inc., A Cambrex Co. | Sep 17, 1997 | SESE |
| K972414 | FRESHCELLS | Diagnostic Hybrids, Inc. | Aug 29, 1997 | SESE |
| K965047 | MINK LUNG CELL CULTURE | Neogenex | Feb 4, 1997 | SESE |
| K962782 | FRESHFROZEN CELLS, HEP-2 | Diagnostic Hybrids, Inc. | Aug 29, 1996 | SESE |
| K962780 | FRESHCELLS, HEP-2 | Diagnostic Hybrids, Inc. | Aug 29, 1996 | SESE |
| K962311 | FRESHFROZENCELLS | Diagnostic Hybrids, Inc. | Aug 29, 1996 | SESE |
| K962306 | FRESH CELLS MULTI-WELL & SHELL VIAL CULTURES | Diagnostic Hybrids, Inc. | Aug 29, 1996 | SESE |
| K955608 | MCCOY CELL CULTURES | Vai Diagnostics, Inc. | Jul 8, 1996 | SESE |
| K960909 | H292 CELL CULTURE | Neogenex | May 30, 1996 | SESE |
| K951461 | NCI-H292 CELL CULTURE | Viromed Laboratories, Inc. | May 22, 1996 | SESE |
| K951440 | LLC-MK2 (MONKEY KIDNEY, MACACA MULATA) CELL CULTURE | Viromed Laboratories, Inc. | May 22, 1996 | SESE |
| K955921 | A549 CELL CULTURE | Viratest Intl., Inc. | Feb 16, 1996 | SESE |
| K952727 | MRC-5 CELL CULTURE VIAL | Viratest Intl., Inc. | Nov 20, 1995 | SESE |
| K942820 | H292 | Bartels, Inc. | May 5, 1995 | SESE |
Top Applicants
- Proteins Intl., Inc. — 51 clearances
- Viromed Laboratories, Inc. — 22 clearances
- Advanced Clinical Diagnostics — 18 clearances
- Earl-Clay Laboratories, Inc. — 17 clearances
- Neogenex — 15 clearances
