KIT — Media And Components, Synthetic Cell And Tissue Culture Class I
FDA product code KIT covers "Media And Components, Synthetic Cell And Tissue Culture", a Class I medical device regulated under 21 CFR 864.2220. Submissions are reviewed by the Hematology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KIT
- Device Class
- Class I
- Regulation Number
- 864.2220
- Submission Type
- Review Panel
- PA
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K892938 | inovar biologicals | AMNIO-GROW TM | May 22, 1989 |
| K890701 | clonetics | ENDOTHELIAL GROWTH MEDIUM (EGM) | February 24, 1989 |
| K890700 | clonetics | MELANOCYTE GROWTH MEDIUM (MGM) | February 24, 1989 |
| K890482 | cell ent | ABC, ABC-1X, ABC(TM) | February 10, 1989 |
| K884654 | hyclone laboratories | ALPHACALF SERUM | November 30, 1988 |
| K884573 | sigma chemical | HBSS W/O CALC CHLOR/MAG SULF/PHEN RED/SB NO. H4891 | November 22, 1988 |
| K884574 | sigma chemical | DME & HAM'S NUTRIENT MIXTURE, PROD. NO. D9785 | November 22, 1988 |
| K884572 | sigma chemical | RPMI-1640 HYBRI-MAX, PROD. NO. R5382 | November 22, 1988 |
| K883065 | osteotech | ALLOPREP SYSTEM | October 13, 1988 |
| K884031 | regency biotech | FBS, EQ., OR FETAL BOVINE SERUM EQUIVALENT | October 6, 1988 |
| K883951 | j r scientific | MEDIUM 199 W/EBSS (CATALOG NO. 200-2037) | September 30, 1988 |
| K883682 | hana biologics | CHANG MEDIUM (ADDITIONAL INDICATIONS) | September 16, 1988 |
| K883630 | j r scientific | RPMI-1640 MEDIUM, CATALOG NO. 210-3525 | September 7, 1988 |
| K883629 | j r scientific | HANK'S BALANCED SALTS (HBSS) CATALOG # 210-3013 | September 7, 1988 |
| K883632 | j r scientific | EX-CELL 300TM, CATALOG NO. 210-3575 | September 7, 1988 |
| K883625 | j r scientific | EX-CELL 301, CATALOG NO. 200-3651 | September 7, 1988 |
| K883626 | j r scientific | EX-CELL 301, CATALOG NO. 210-3577 | September 7, 1988 |
| K883624 | j r scientific | EX-CELL 300TM, CATALOG NO. 200-3601 | September 7, 1988 |
| K883623 | j r scientific | EX-CELL 300TM, CATALOG NO. 200-3600 | September 7, 1988 |
| K883631 | j r scientific | EX-CELL 300TM, CATALOG # 210-3579 | September 7, 1988 |