Product code KIT
- Device name
- Media And Components, Synthetic Cell And Tissue Culture
- Medical specialty
- Hematology
- Device class
- 1
- Regulation number
- 864.2220
- 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 |
|---|---|---|---|
| K892938 | AMNIO-GROW TM | Inovar Biologicals, Inc. | 1989-05-22 |
| K890701 | ENDOTHELIAL GROWTH MEDIUM (EGM) | Clonetics Corp. | 1989-02-24 |
| K890700 | MELANOCYTE GROWTH MEDIUM (MGM) | Clonetics Corp. | 1989-02-24 |
| K890482 | ABC, ABC-1X, ABC(TM) | Cell Ent., Inc. | 1989-02-10 |
| K884654 | ALPHACALF SERUM | Hyclone Laboratories, Inc. | 1988-11-30 |
| K884574 | DME & HAM'S NUTRIENT MIXTURE, PROD. NO. D9785 | Sigma Chemical Co. | 1988-11-22 |
| K884573 | HBSS W/O CALC CHLOR/MAG SULF/PHEN RED/SB NO. H4891 | Sigma Chemical Co. | 1988-11-22 |
| K884572 | RPMI-1640 HYBRI-MAX, PROD. NO. R5382 | Sigma Chemical Co. | 1988-11-22 |
| K883065 | ALLOPREP SYSTEM | Osteotech, Inc. | 1988-10-13 |
| K884031 | FBS, EQ., OR FETAL BOVINE SERUM EQUIVALENT | Regency Biotech | 1988-10-06 |
| K883951 | MEDIUM 199 W/EBSS (CATALOG NO. 200-2037) | J R Scientific | 1988-09-30 |
| K883682 | CHANG MEDIUM (ADDITIONAL INDICATIONS) | Hana Biologics, Inc. | 1988-09-16 |
| K883627 | MIN ESSENT MED EAGLE, JOKLIK MOD, CAT. #200-2150 | J R Scientific | 1988-09-07 |
| K883623 | EX-CELL 300TM, CATALOG NO. 200-3600 | J R Scientific | 1988-09-07 |
| K883624 | EX-CELL 300TM, CATALOG NO. 200-3601 | J R Scientific | 1988-09-07 |
| K883625 | EX-CELL 301, CATALOG NO. 200-3651 | J R Scientific | 1988-09-07 |
| K883626 | EX-CELL 301, CATALOG NO. 210-3577 | J R Scientific | 1988-09-07 |
| K883628 | MIN ESSENT MED EAGLE FOR SPINN CULTURE, #200-2051 | J R Scientific | 1988-09-07 |
| K883629 | HANK'S BALANCED SALTS (HBSS) CATALOG # 210-3013 | J R Scientific | 1988-09-07 |
| K883630 | RPMI-1640 MEDIUM, CATALOG NO. 210-3525 | J R Scientific | 1988-09-07 |
| K883631 | EX-CELL 300TM, CATALOG # 210-3579 | J R Scientific | 1988-09-07 |
| K883632 | EX-CELL 300TM, CATALOG NO. 210-3575 | J R Scientific | 1988-09-07 |
| K883451 | SFRE 199-1 MEDIUM, CATALOG NO. 200-2191 | J R Scientific | 1988-08-30 |
| K883446 | FETAL BOVINE SERUM, GAMMA IRRADIATED NO. 110-1122 | J R Scientific | 1988-08-29 |
| K883366 | MEDIUM 199, CATALOG NO. 200-2031 | J R Scientific | 1988-08-29 |
| K883445 | HANKS' BALANCED SALTS (HBSS) 10X, NO. 210-3012 | J R Scientific | 1988-08-29 |
| K883370 | FISCHER'S MEDIUM CATALOG NO. 210-4007 | J R Scientific | 1988-08-29 |
| K883369 | L-15 MEDIUM, CATALOG NO. 210-4004 | J R Scientific | 1988-08-29 |
| K883364 | ISCOVE'S MODIFIED DELBECCO'S MEDIUM NO.210-3505 | J R Scientific | 1988-08-29 |
| K883362 | L-15 MEDIUM, CATALOG NO. 200-2021 | J R Scientific | 1988-08-29 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00840075404729 | TheraPEAK X-VIVO™ 15 without Gentamicin or Phenol Red | Lonza Walkersville, Inc. | 2026-05-27 |
| 10190302001236 | Minimum Essential Medium (MEM) (1X) | LIFE TECHNOLOGIES LIMITED | 2023-10-02 |
| 10190302002394 | Iscove's Modified Dulbecco's Medium (IMDM) | LIFE TECHNOLOGIES CORPORATION | 2016-08-01 |
| 10190302002387 | Iscove's Modified Dulbecco's Medium (IMDM) | LIFE TECHNOLOGIES CORPORATION | 2016-08-01 |
| 10190302002264 | MarrowMAX™ Bone Marrow Medium | LIFE TECHNOLOGIES CORPORATION | 2016-08-01 |
| 10190302002257 | MarrowMAX™ Bone Marrow Medium | LIFE TECHNOLOGIES CORPORATION | 2016-08-01 |
| 10190302002202 | Minimum Essential Medium (MEM) Alpha | LIFE TECHNOLOGIES CORPORATION | 2016-08-01 |
| 10190302002073 | Minimum Essential Medium (MEM) Alpha | LIFE TECHNOLOGIES CORPORATION | 2016-08-01 |
| 10190302002059 | Minimum Essential Medium Alpha | LIFE TECHNOLOGIES LIMITED | 2016-08-01 |
| 10190302001991 | RPMI Medium 1640 | LIFE TECHNOLOGIES CORPORATION | 2016-08-01 |
| 10190302001984 | RPMI Medium 1640 | LIFE TECHNOLOGIES CORPORATION | 2016-08-01 |
| 10190302001977 | RPMI Medium 1640 | LIFE TECHNOLOGIES CORPORATION | 2016-08-01 |
| 10190302001953 | RPMI Medium 1640, no phenol red | LIFE TECHNOLOGIES CORPORATION | 2016-08-01 |
| 10190302001939 | F-12 Nutrient Mix (Ham) | LIFE TECHNOLOGIES CORPORATION | 2016-08-01 |
| 10190302001922 | F-12 Nutrient Mix (Ham) | LIFE TECHNOLOGIES CORPORATION | 2016-08-01 |
| 10190302001908 | Minimum Essential Medium (MEM), Earles's | LIFE TECHNOLOGIES CORPORATION | 2016-08-01 |
| 10190302001861 | Leibovitz's L-15 Medium | LIFE TECHNOLOGIES CORPORATION | 2016-08-01 |
| 10190302001793 | DMEM/F-12 | LIFE TECHNOLOGIES CORPORATION | 2016-08-01 |
| 10190302001786 | DMEM/F-12 | LIFE TECHNOLOGIES CORPORATION | 2016-08-01 |
| 10190302001762 | AmnioMAX™-II Complete Medium | LIFE TECHNOLOGIES CORPORATION | 2016-08-01 |
| 10190302001748 | Medium 199, Earle's | LIFE TECHNOLOGIES CORPORATION | 2016-08-01 |
| 10190302001731 | MEM Non-Essential Amino Acids Solution (100X) | LIFE TECHNOLOGIES CORPORATION | 2016-08-01 |
| 10190302001663 | MEM Earles | LIFE TECHNOLOGIES CORPORATION | 2016-08-01 |
| 10190302001656 | MEM Earles | LIFE TECHNOLOGIES CORPORATION | 2016-08-01 |
| 10190302001649 | MEM Earles | LIFE TECHNOLOGIES CORPORATION | 2016-08-01 |
| 10190302001625 | Opti-MEM™ I Reduced Serum Medium, no phenol red | LIFE TECHNOLOGIES CORPORATION | 2016-08-01 |
| 10190302001601 | Minimum Essential Medium | LIFE TECHNOLOGIES LIMITED | 2016-08-01 |
| 10190302001595 | Dulbecco's Modified Eagle Medium (DMEM) | LIFE TECHNOLOGIES LIMITED | 2016-08-01 |
| 10190302001465 | DMEM/F12 + GlutaMAX™ -l (1X) | LIFE TECHNOLOGIES CORPORATION | 2016-08-01 |
| 10190302001250 | Minimum Essential Medium (MEM) | LIFE TECHNOLOGIES CORPORATION | 2016-08-01 |