Atlas FDA

KIT

367 FDA 510(k) clearances · Product code

20 daysmedian time to decision
51 days90th percentile
367clearances measured

FDA profile

Official device name
Media And Components, Synthetic Cell And Tissue Culture
Device class
Class I (low risk)
Regulation
21 CFR 864.2220
Medical specialty
Hematology
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RecordFirmDate
AMNIO-GROW TM (K892938)Inovar Biologicals, Inc.1989-05-22
ENDOTHELIAL GROWTH MEDIUM (EGM) (K890701)Clonetics Corp.1989-02-24
MELANOCYTE GROWTH MEDIUM (MGM) (K890700)Clonetics Corp.1989-02-24
ABC, ABC-1X, ABC(TM) (K890482)Cell Ent., Inc.1989-02-10
ALPHACALF SERUM (K884654)Hyclone Laboratories, Inc.1988-11-30
HBSS W/O CALC CHLOR/MAG SULF/PHEN RED/SB NO. H4891 (K884573)Sigma Chemical Co.1988-11-22
RPMI-1640 HYBRI-MAX, PROD. NO. R5382 (K884572)Sigma Chemical Co.1988-11-22
DME & HAM'S NUTRIENT MIXTURE, PROD. NO. D9785 (K884574)Sigma Chemical Co.1988-11-22
ALLOPREP SYSTEM (K883065)Osteotech, Inc.1988-10-13
FBS, EQ., OR FETAL BOVINE SERUM EQUIVALENT (K884031)Regency Biotech1988-10-06
MEDIUM 199 W/EBSS (CATALOG NO. 200-2037) (K883951)J R Scientific1988-09-30
CHANG MEDIUM (ADDITIONAL INDICATIONS) (K883682)Hana Biologics, Inc.1988-09-16
EX-CELL 301, CATALOG NO. 200-3651 (K883625)J R Scientific1988-09-07
EX-CELL 300TM, CATALOG NO. 200-3601 (K883624)J R Scientific1988-09-07
MIN ESSENT MED EAGLE FOR SPINN CULTURE, #200-2051 (K883628)J R Scientific1988-09-07
MIN ESSENT MED EAGLE, JOKLIK MOD, CAT. #200-2150 (K883627)J R Scientific1988-09-07
HANK'S BALANCED SALTS (HBSS) CATALOG # 210-3013 (K883629)J R Scientific1988-09-07
EX-CELL 300TM, CATALOG # 210-3579 (K883631)J R Scientific1988-09-07
EX-CELL 300TM, CATALOG NO. 200-3600 (K883623)J R Scientific1988-09-07
EX-CELL 300TM, CATALOG NO. 210-3575 (K883632)J R Scientific1988-09-07
EX-CELL 301, CATALOG NO. 210-3577 (K883626)J R Scientific1988-09-07
RPMI-1640 MEDIUM, CATALOG NO. 210-3525 (K883630)J R Scientific1988-09-07
SFRE 199-1 MEDIUM, CATALOG NO. 200-2191 (K883451)J R Scientific1988-08-30
L-15 MEDIUM, CATALOG NO. 200-2021 (K883362)J R Scientific1988-08-29
L-15 MEDIUM, CATALOG NO. 210-4004 (K883369)J R Scientific1988-08-29
FISCHER'S MEDIUM CATALOG NO. 210-4007 (K883370)J R Scientific1988-08-29
ISCOVE'S MODIFIED DELBECCO'S MEDIUM NO.200-2105 (K883363)J R Scientific1988-08-29
ISCOVE'S MODIFIED DELBECCO'S MEDIUM NO.210-3505 (K883364)J R Scientific1988-08-29
MINIMUM ESSENTIAL MEDIUM EAGLE, NO. 200-2048 (K883449)J R Scientific1988-08-29
CALF SERUM, CATALOG NO. 110-1125 (K883367)J R Scientific1988-08-29
HANKS' BALANCED SALTS (HBSS) 10X, NO. 210-3012 (K883445)J R Scientific1988-08-29
MINIMUM ESSENTIAL MEDIUM EAGLE (MEM), 210-3517 (K883496)J R Scientific1988-08-29
MCCOY'S 5A MEDIUM (CATALOG NO. 210-3531) (K883501)J R Scientific1988-08-29
FETAL BOVINE SERUM, DEFINED NO. 110-1121 (K883502)J R Scientific1988-08-29
MINIMUM ESSENTIAL MEDIUM EAGLE NO. 200-2046 (K883448)J R Scientific1988-08-29
FETAL BOVINE SERUM, HEAT INACTIVATED NO.110-1123 (K883498)J R Scientific1988-08-29
FETAL BOVINE SERUM, GAMMA IRRADIATED NO. 110-1122 (K883446)J R Scientific1988-08-29
MEDIUM 199, 10X CATALOG NO. 210-3556 (K883497)J R Scientific1988-08-29
HORSE SERUM, ABATTOIR, NO. 110-1112 (K883365)J R Scientific1988-08-29
MEDIUM 199, 10X, CATALOG NO. 210-3557 (K883499)J R Scientific1988-08-29
MCCOY'S 5A MEDIUM 10X NO. 210-3532 (K883500)J R Scientific1988-08-29
SFRE 199-2 MEDIUM, CATALOG NO. 200-2192 (K883450)J R Scientific1988-08-29
MEDIUM 199, 10X, CATALOG NO. 210-3555 (K883495)J R Scientific1988-08-29
NEWBORN CALF SERUM, CATALOG NO. 110-1130 (K883368)J R Scientific1988-08-29
MEDIUM 199, CATALOG NO. 200-2031 (K883366)J R Scientific1988-08-29
MINIMUM ESSENTIAL MEDIUM EAGLE 10X, NO.210-3511 (K883447)J R Scientific1988-08-29
DONOR HORSE SERUM, CAT. NO. 110-1110 (K883291)J R Scientific1988-08-15
CMRL 1969 MAINTENANCE MEDIUM CAT, # 200-2177 (K883138)J R Scientific1988-08-15
RPMI-1640 W/25MM HEPES BUFF W/O SOD BICAR 200-2120 (K883141)J R Scientific1988-08-15
NEWBORN CALF SERUM, HEAT INACTIVATED # 110-1131 (K883286)J R Scientific1988-08-15
DONOR BOVINE SERUM, CAT. NO. 110-1116 (K883290)J R Scientific1988-08-15
MEDIUM 199 EBSS/NUTRIENT MIXTURE F-10 #200-2110 (K883139)J R Scientific1988-08-15
CALF SERUM, GAMMA IRRADIATED, CAT. NO. 110-1126 (K883287)J R Scientific1988-08-15
DONOR HORSE SERUM, HEAT INACTIVATED, #110-1113 (K883288)J R Scientific1988-08-15
FETAL BOVINE SERUM, CAT. NO. 110-1120 (K883285)J R Scientific1988-08-15
MINIMUM ESSENTIAL MED (MEM,THERMO-POW(R)#200-2090 (K883140)J R Scientific1988-08-15
BOVINE SERUM, CAT. LNO. 110-1115 (K883292)J R Scientific1988-08-15
CALF SERUM, HEAT INACTIVATED, CAT. # 110-1127 (K883289)J R Scientific1988-08-15
NUTRIENT MIXTURE F-12 (HAM) NO. 200-2071 (K882993)J R Scientific1988-08-04
MCCOY'S 5A MEDIUM NO. 210-3530 (K882986)J R Scientific1988-08-04
RPMI-1640 BAKER'S MODIFICATION NO. 200-2078 (K882990)J R Scientific1988-08-04
(DME/F-12 1:1), CATALOG NO. 200-2100 (K882997)J R Scientific1988-08-04
NUTRIENT MIXTURE F-12 (HAT VARIATION) NO. 200-2070 (K882991)J R Scientific1988-08-04
MINIMUM ESSENTIAL MEDIUM, ALPHA MODI. NO.200-2091 (K882992)J R Scientific1988-08-04
FISCHER'S MEDIUM NO. 200-2188 (K882995)J R Scientific1988-08-04
FISCHER'S MEDIUM NO. 200-2184 (K882985)J R Scientific1988-08-04
MEDIUM 199, NO. 200-2035 (K882984)J R Scientific1988-08-04
DULBECCO'S MODIFIED EAGLE'S MEDIUM NO. 210-3540 (K882988)J R Scientific1988-08-04
DULBECCO'S MODIFIED EAGLE'S MEDIUM NO. 210-3502 (K882989)J R Scientific1988-08-04
KREBS-HENSELEIT BICARBONATE BUFFER NO. K3753 (K882965)Sigma Chemical Co.1988-08-04
MEDIUM 199, CATALOG NO. 210-3535 (K882983)J R Scientific1988-08-04
DULBECCO'S PHOSPHATE BUFFERED SALINE NO.210-3022 (K882996)J R Scientific1988-08-04
DULBECCO'S PHOSPHATE BUFFERED SALINE NO. 210-3021 (K882994)J R Scientific1988-08-04
DULBECCO'S MODIFIED EAGLE'S MEDIUM NO. 200-2009 (K882987)J R Scientific1988-08-04
MEDIUM 199, CATALOG NO. 210-3536 (K882854)J R Scientific1988-08-01
MINIMUM ESSENTIAL MEDIUM EAGLE NO. 210-3510 (K882860)J R Scientific1988-08-01
RPMI-1640 MEDIUM, CATALOG NO. 210-3521 (K882848)J R Scientific1988-08-01
DULBECCO'S MODIFIED EAGLE'S MEDIUM NO. 210-3500 (K882849)J R Scientific1988-08-01
MINIMUM ESSENTIAL MEDIUM EAGLE NO. 210-3515 (K882847)J R Scientific1988-08-01
DULBECCO'S MODIFIED EAGLE'S MEDIUM NO. 210-3501 (K882846)J R Scientific1988-08-01
RPMI-1640 MEDIUM, CATALOG NO. 210-3523 (K882851)J R Scientific1988-08-01
RPMI-1640 MEDIUM, CATALOG NO. 210-3520 (K882853)J R Scientific1988-08-01
DULBECCO'S MODIFIED EAGLE'S MEDIUM, NO. 200-2183 (K882837)J R Scientific1988-08-01
MINIMUM ESSENTIAL MEDIUM EAGLE (MEM) NO. 210-3512 (K882863)J R Scientific1988-08-01
NUTRIENT MIXTURE F-10 (HAM) NO. 210-3550 (K882850)J R Scientific1988-08-01
MINIMUM ESSENTIAL MEDIUM EAGLE NO. 210-3514 (K882861)J R Scientific1988-08-01
DULBECCO'S PHOSPHATE BUFFERED SALINE NO. 210-3025 (K882865)J R Scientific1988-07-28
HANK'S BALANCED SALTS NO. 200-2510 (K882844)J R Scientific1988-07-28
NUTRIENT MIXTURE F-12 (HAM), NO. 210-3551 (K882858)J R Scientific1988-07-28
DULBECCO'S PHOSPHATE BUFFERED SALINE, NO 200-2525 (K882852)J R Scientific1988-07-28
EARLE'S BALANCED SALTS NO. 200-2500 (K882845)J R Scientific1988-07-28
EARLE'S BALANCED SALTS (EBSS) NO. 200-2505 (K882842)J R Scientific1988-07-28
HANK'S BALANCED SALTS (HBSS) NO. 200-2521 (K882841)J R Scientific1988-07-28
DULBECCO'S PHOSPHATE BUFFERED SALINE NO. 210-3020 (K882859)J R Scientific1988-07-28
HANKS' BALANCED SALT SOLUTION (HBSS) NO. 210-3011 (K882864)J R Scientific1988-07-28
MINIMUM ESSENTIAL MEDIUM EAGLE, NO. 200-2180 (K882838)J R Scientific1988-07-28
HANKS' BALANCED SALT SOLUTION NO. 210-3015 (K882855)J R Scientific1988-07-28
EARLE'S BALANCED SALTS (EBSS) NO. 200-2506 (K882839)J R Scientific1988-07-28
HANK'S BALANCED SALTS NO. 200-2515 (K882843)J R Scientific1988-07-28
HANKS' BALANCED SALTS NO. 210-3010 (K882857)J R Scientific1988-07-28
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