Life Technologies, Corp.
FDA Regulatory Profile
Summary
- Total Recalls
- 10
- 510(k) Clearances
- 4
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0171-2019 | Class II | Gibco MEM Non-Essential Amino Acids Solution (100X) (SKU 11140050), for In-Vitro Diagnostic Use | August 24, 2018 |
| Z-0173-2019 | Class II | Gibco Sodium Pyruvate (100 mM) SKU 11360070, for In-Vitro Diagnostic Use | August 24, 2018 |
| Z-0172-2019 | Class II | Gibco DPBS, calcium, magnesium, for In-Vitro Diagnostic Use SKU 14040141 | August 24, 2018 |
| Z-0174-2019 | Class II | Gibco GlutaMAX Supplement, for In-Vitro Diagnostic Use SKU 35050061 | August 24, 2018 |
| Z-2543-2018 | Class II | GIBCO CTS AIM V Serum-Free Media (SFM), Model Number 0870112BK. Tissue and cell culture medium. | May 10, 2018 |
| Z-2546-2018 | Class II | Gibco RPMI 1640 Medium, Model Number 61870150. Tissue and cell culture medium. | May 10, 2018 |
| Z-2545-2018 | Class II | Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, Model Number 11965175. Tissue and cell | May 10, 2018 |
| Z-2542-2018 | Class II | Gibco CTS OpTmizer T Cell Expansion Serum Free Medium, bag format, Model Numbers A1048503 and A10221 | May 10, 2018 |
| Z-2544-2018 | Class II | Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, pyruvate, Model Number 11995115. Tissu | May 10, 2018 |
| Z-2547-2018 | Class II | Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, pyruvate, Model Number 11995123. Tissu | May 10, 2018 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K113566 | OPTMIZER CTS T-CELL EXPANSION SERUM FREE MEDIUM | June 21, 2012 |
| DEN000008 | DULBECCO'S MODIFIED EAGLE MEDIUM (DMEM) | February 16, 2001 |
| K953719 | HUMAN TUBAL FLUID | November 6, 1995 |
| K951835 | MODIFIED HUMAN TUBAL FLUID (MHTF) WITH/WITHOUT PENICILLIN G DOLIUM, WITH/WITHOUT STREPTOMYCIN SULFAT | August 11, 1995 |