MRC-5 Culture Cell
FDA 510(k) K933925 · Neogenex
510(k) numberK933925
Submission
- Device name
- MRC-5 Culture Cell
- Applicant
- Neogenex
Everett, WA, US - Received
- August 10, 1993
- Decision date
- March 29, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KIR – Cells, Animal And Human, Cultured
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.2280
- Specialty
- Hematology
Other 510(k)s with product code KIR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K973214 | Fresh Cells HFFKIR · Traditional | Diagnostic Hybrids, Inc. | 09/25/1997SE |
| K973213 | Fresh Cells LLC-MK2KIR · Traditional | Diagnostic Hybrids, Inc. | 09/25/1997SE |
| K973212 | Fresh Cells WI-38KIR · Traditional | Diagnostic Hybrids, Inc. | 09/25/1997SE |
| K973211 | Fresh Cells MV1LUKIR · Traditional | Diagnostic Hybrids, Inc. | 09/25/1997SE |
| K973210 | Fresh Cells Nci H292KIR · Traditional | Diagnostic Hybrids, Inc. | 09/25/1997SE |
| K973209 | Fresh Cells VeroKIR · Traditional | Diagnostic Hybrids, Inc. | 09/25/1997SE |
| K971508 | RHMK II Cell Culture, an Expanded Primary Rhesus Monkey Kidney Cell CultureKIR · Traditional | Bio-Whittaker, Inc., A Cambrex Co. | 09/17/1997SE |
| K972414 | FreshcellsKIR · Traditional | Diagnostic Hybrids, Inc. | 08/29/1997SE |
| K965047 | Mink Lung Cell CultureKIR · Traditional | Neogenex | 02/04/1997SE |
| K962782 | Freshfrozen Cells, HEP-2KIR · Traditional | Diagnostic Hybrids, Inc. | 08/29/1996SE |
More from Diagnostic Hybrids, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K965047 | Mink Lung Cell CultureKIR · Traditional | 02/04/1997SE |
| K960909 | H292 Cell CultureKIR · Traditional | 05/30/1996SE |
| K943891 | RD Culture CellKIR · Traditional | 11/28/1994SE |
| K943890 | WI38 Cell CultureKIR · Traditional | 11/28/1994SE |
| K943889 | Vero Cell CultureKIR · Traditional | 11/28/1994SE |
| K943888 | MDCK Cell CultureKIR · Traditional | 11/28/1994SE |
| K943887 | Human Newborn Foreskin Cell CultureKIR · Traditional | 11/28/1994SE |
| K943886 | BGM Cell CultureKIR · Traditional | 11/28/1994SE |
| K943885 | Primary Rabbit Kidney Cell CultureKIR · Traditional | 11/28/1994SE |
| K943884 | Primary Monkey Kidney Cell CultureKIR · Traditional | 11/28/1994SE |
Questions and answers
When was MRC-5 Culture Cell cleared by the FDA?
MRC-5 Culture Cell (K933925) received a 510(k) decision of Substantially Equivalent on March 29, 1994, 231 days after the submission was received.
What is the product code of K933925?
The FDA product code is KIR – Cells, Animal And Human, Cultured, a Class I (low risk) device regulated under 21 CFR 864.2280.