KIT · Media And Components, Synthetic Cell And Tissue Culture
Hematology · 21 CFR 864.2220 · Class 1
Overview
| Product Code | KIT |
|---|---|
| Device Name | Media And Components, Synthetic Cell And Tissue Culture |
| Regulation | 21 CFR 864.2220 |
| Device Class | Class 1 |
| Review Panel | Hematology |
Identification
Synthetic cell and tissue culture media and components are substances that are composed entirely of defined components (e.g., amino acids, vitamins, inorganic salts) that are essential for the survival and development of cell lines of humans and other animals. This does not include tissue culture media for human ex vivo tissue and cell culture processing applications as described in § 876.5885 of this chapter.
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 the limitations in § 864.9.
Recent Cleared Devices (20 of 367)
Showing 20 most recent of 367 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K892938 | AMNIO-GROW TM | Inovar Biologicals, Inc. | May 22, 1989 | SESE |
| K890701 | ENDOTHELIAL GROWTH MEDIUM (EGM) | Clonetics Corp. | Feb 24, 1989 | SESE |
| K890700 | MELANOCYTE GROWTH MEDIUM (MGM) | Clonetics Corp. | Feb 24, 1989 | SESE |
| K890482 | ABC, ABC-1X, ABC(TM) | Cell Ent., Inc. | Feb 10, 1989 | SESE |
| K884654 | ALPHACALF SERUM | Hyclone Laboratories, Inc. | Nov 30, 1988 | SESE |
| K884574 | DME & HAM'S NUTRIENT MIXTURE, PROD. NO. D9785 | Sigma Chemical Co. | Nov 22, 1988 | SESE |
| K884573 | HBSS W/O CALC CHLOR/MAG SULF/PHEN RED/SB NO. H4891 | Sigma Chemical Co. | Nov 22, 1988 | SESE |
| K884572 | RPMI-1640 HYBRI-MAX, PROD. NO. R5382 | Sigma Chemical Co. | Nov 22, 1988 | SESE |
| K883065 | ALLOPREP SYSTEM | Osteotech, Inc. | Oct 13, 1988 | SESE |
| K884031 | FBS, EQ., OR FETAL BOVINE SERUM EQUIVALENT | Regency Biotech | Oct 6, 1988 | SESE |
| K883951 | MEDIUM 199 W/EBSS (CATALOG NO. 200-2037) | J R Scientific | Sep 30, 1988 | SESE |
| K883682 | CHANG MEDIUM (ADDITIONAL INDICATIONS) | Hana Biologics, Inc. | Sep 16, 1988 | SESE |
| K883632 | EX-CELL 300TM, CATALOG NO. 210-3575 | J R Scientific | Sep 7, 1988 | SESE |
| K883631 | EX-CELL 300TM, CATALOG # 210-3579 | J R Scientific | Sep 7, 1988 | SESE |
| K883630 | RPMI-1640 MEDIUM, CATALOG NO. 210-3525 | J R Scientific | Sep 7, 1988 | SESE |
| K883629 | HANK'S BALANCED SALTS (HBSS) CATALOG # 210-3013 | J R Scientific | Sep 7, 1988 | SESE |
| K883628 | MIN ESSENT MED EAGLE FOR SPINN CULTURE, #200-2051 | J R Scientific | Sep 7, 1988 | SESE |
| K883627 | MIN ESSENT MED EAGLE, JOKLIK MOD, CAT. #200-2150 | J R Scientific | Sep 7, 1988 | SESE |
| K883626 | EX-CELL 301, CATALOG NO. 210-3577 | J R Scientific | Sep 7, 1988 | SESE |
| K883625 | EX-CELL 301, CATALOG NO. 200-3651 | J R Scientific | Sep 7, 1988 | SESE |
Top Applicants
- J R Scientific — 132 clearances
- Sigma Chemical Co. — 87 clearances
- Dutchland Laboratories, Inc. — 42 clearances
- Hazleton Research Products, Inc. — 34 clearances
- Mediatech, Inc. — 23 clearances
