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KIT — Media And Components, Synthetic Cell And Tissue Culture Class I

FDA Device Classification

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-NumberApplicantDevice NameDate
K892938inovar biologicalsAMNIO-GROW TMMay 22, 1989
K890700cloneticsMELANOCYTE GROWTH MEDIUM (MGM)February 24, 1989
K890701cloneticsENDOTHELIAL GROWTH MEDIUM (EGM)February 24, 1989
K890482cell entABC, ABC-1X, ABC(TM)February 10, 1989
K884654hyclone laboratoriesALPHACALF SERUMNovember 30, 1988
K884572sigma chemicalRPMI-1640 HYBRI-MAX, PROD. NO. R5382November 22, 1988
K884573sigma chemicalHBSS W/O CALC CHLOR/MAG SULF/PHEN RED/SB NO. H4891November 22, 1988
K884574sigma chemicalDME & HAM'S NUTRIENT MIXTURE, PROD. NO. D9785November 22, 1988
K883065osteotechALLOPREP SYSTEMOctober 13, 1988
K884031regency biotechFBS, EQ., OR FETAL BOVINE SERUM EQUIVALENTOctober 6, 1988
K883951j r scientificMEDIUM 199 W/EBSS (CATALOG NO. 200-2037)September 30, 1988
K883682hana biologicsCHANG MEDIUM (ADDITIONAL INDICATIONS)September 16, 1988
K883628j r scientificMIN ESSENT MED EAGLE FOR SPINN CULTURE, #200-2051September 7, 1988
K883624j r scientificEX-CELL 300TM, CATALOG NO. 200-3601September 7, 1988
K883632j r scientificEX-CELL 300TM, CATALOG NO. 210-3575September 7, 1988
K883631j r scientificEX-CELL 300TM, CATALOG # 210-3579September 7, 1988
K883626j r scientificEX-CELL 301, CATALOG NO. 210-3577September 7, 1988
K883625j r scientificEX-CELL 301, CATALOG NO. 200-3651September 7, 1988
K883627j r scientificMIN ESSENT MED EAGLE, JOKLIK MOD, CAT. #200-2150September 7, 1988
K883630j r scientificRPMI-1640 MEDIUM, CATALOG NO. 210-3525September 7, 1988