510(k) K971508
- Device
- RHMK II CELL CULTURE, AN EXPANDED PRIMARY RHESUS MONKEY KIDNEY CELL CULTURE
- Applicant
- Bio-Whittaker, Inc., A Cambrex Co.
- 510(k) number
- K971508
- Product code
- KIR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-09-17
- Date received
- 1997-04-25
- Regulation
- 864.2280
- Classification name
- Cells, Animal And Human, Cultured
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- LEIF E OLSEN
- Address
- 8830 Biggs Ford Rd. Walkersville MD US 21793 21793
FDA Registration Numbers#
- 2022180
- 3005248192
- 3010194621
- 3009189893
- 2916205
- 2028492
- 1528450
Source Documents#
Other 510(k) Records For Product Code KIR#
| 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 |
| 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 |