FDA Product Code
FDA Product Code KIT — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.2220
510(k) Clearances — 367 records · page 3 of 4
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K860282 | RPMI 1640 W/GLUTAMINE W/HEPES | Newport Biosystems, Inc. | 1986-02-05 | Traditional | PDF ↗ |
| K855085 | TISSUE CULTURE MEDIA | Newport Biosystems, Inc. | 1986-01-13 | Traditional | PDF ↗ |
| K854567 | PENICILLIN/STREPTOMYCIN SOLUTION | Mediatech, Inc. | 1985-12-06 | Traditional | PDF ↗ |
| K852602 | MCCOY'S 5A MEDIUM-LIQUID FORM | Mediatech, Inc. | 1985-07-12 | Traditional | PDF ↗ |
| K852485 | CELLGRO(ISCOVE'S MEDIUM) MODIFICATION | Mediatech, Inc. | 1985-07-12 | Traditional | PDF ↗ |
| K852475 | CELLGRO WILLIAMS' MEDIUM E | Mediatech, Inc. | 1985-07-12 | Traditional | PDF ↗ |
| K852568 | MCDB 201 MED CAT NO. M6770 W/ HEPES & W0/ BICARBON | Sigma Chemical Co. | 1985-07-12 | Traditional | PDF ↗ |
| K852288 | CELLGRO | Mediatech, Inc. | 1985-06-04 | Traditional | PDF ↗ |
| K851862 | MCDB 302 MEDIUM, M2021 | Sigma Cell Culture Reagents | 1985-05-20 | Traditional | PDF ↗ |
| K851863 | NCTC-135 MEDIUM N3262 | Sigma Cell Culture Reagents | 1985-05-20 | Traditional | PDF ↗ |
| K851605 | SWIN'S S-77 MEDIUM, PRODUCTS S2513 | Sigma Chemical Co. | 1985-05-15 | Traditional | PDF ↗ |
| K851606 | D-PBS, PRODUCTS NO. D5652 | Sigma Chemical Co. | 1985-05-15 | Traditional | PDF ↗ |
| K851737 | MCDB-110 MED. M6520 W/L-GLUTAMINE-25M M HERPES & | Sigma | 1985-05-15 | Traditional | PDF ↗ |
| K851608 | SFRE199-1 MEDIUM PRODUCT NO. S 2013 | Sigma Chemical Co. | 1985-05-15 | Traditional | PDF ↗ |
| K851738 | MCDB-105 MED. M6395, W/L-GLUTAMINE, 25M M HERPES & | Sigma | 1985-05-15 | Traditional | PDF ↗ |
| K851609 | SFRE 199-2 MEDIUM, PRODUCTS NO. S2138 | Sigma Chemical Co. | 1985-05-15 | Traditional | PDF ↗ |
| K851604 | CRCM-30 MEDIUM PRODUCT NO. C5030 | Sigma Chemical Co. | 1985-05-15 | Traditional | PDF ↗ |
| K851607 | MCDB 151 MEDIUM, PRODUCT NO. M6645 | Sigma Chemical Co. | 1985-05-15 | Traditional | PDF ↗ |
| K850886 | COMPRESSION HIP SCREW SYSTEM | Pfizer, Inc. | 1985-04-19 | Traditional | PDF ↗ |
| K850990 | HFF GENCELLS | Bioassay Systems Research Corp. | 1985-04-12 | Traditional | PDF ↗ |
| K850679 | TRYPSIN-EDTA SOLUTION | Hazleton Research Products, Inc. | 1985-03-29 | Traditional | PDF ↗ |
| K850890 | MCCOY'S 5A M9270 W/L-GLUTAMINE & W/O PHENOL RED & | Sigma Chemical Co. | 1985-03-25 | Traditional | PDF ↗ |
| K850891 | DULBECCO'S MODIFIED EAGLE'S MEDIUM D7777, W/L-GLUT | Sigma Chemical Co. | 1985-03-25 | Traditional | PDF ↗ |
| K850922 | MEM D-VAL MODIF. M7395, W/EBSS, L-GLUTAMINE, D-VAL | Sigma Chemical Co. | 1985-03-25 | Traditional | PDF ↗ |
| K850921 | MEM, M7270, W/EBSS, L-GLUTAMINE & W/O L-LEUCINE - | Sigma Chemical Co. | 1985-03-25 | Traditional | PDF ↗ |
| K850537 | CELL CULTURE REFEED MEDIUM | Hillcrest Biologicals | 1985-03-20 | Traditional | PDF ↗ |
| K850227 | HAM'S MIXTURE F-12 MEDIUM | Hazleton Research Products, Inc. | 1985-03-11 | Traditional | PDF ↗ |
| K850217 | CYNOMOLGUS MONKEY BLOOD IN ALSEVER'S | Hazleton Research Products, Inc. | 1985-03-07 | Traditional | PDF ↗ |
| K850218 | SWIM'S S-77 POWDER MEDIUM | Hazleton Research Products, Inc. | 1985-03-07 | Traditional | PDF ↗ |
| K850232 | E.MEM POWDERED MEDIUM | Hazleton Research Products, Inc. | 1985-03-07 | Traditional | PDF ↗ |
| K850226 | MCCOY'S MEDIUM 5A, IWAKATA & GRACE MODIFICA- | Hazleton Research Products, Inc. | 1985-03-07 | Traditional | PDF ↗ |
| K850235 | BME VITAMINS 100X | Hazleton Research Products, Inc. | 1985-03-07 | Traditional | PDF ↗ |
| K850220 | ALPHA MEM W/O NUCLEOSIDES POWDER MEDIUM | Hazleton Research Products, Inc. | 1985-03-07 | Traditional | PDF ↗ |
| K850234 | H-MEM POWDERED MEDIUM | Hazleton Research Products, Inc. | 1985-03-07 | Traditional | PDF ↗ |
| K850236 | BME AMINO ACIDS 100X | Hazleton Research Products, Inc. | 1985-03-07 | Traditional | PDF ↗ |
| K850233 | MEM ESSENTIAL AMINO ACIDS 50X | Hazleton Research Products, Inc. | 1985-03-07 | Traditional | PDF ↗ |
| K850223 | EARLE'S MEM W/NON-ESSENTIAL AMINO ACIDS POWDER MED | Hazleton Research Products, Inc. | 1985-03-07 | Traditional | PDF ↗ |
| K850225 | FISCHER'S MEDIUM | Hazleton Research Products, Inc. | 1985-03-07 | Traditional | PDF ↗ |
| K850219 | MEM W/SPINNER SALTS POWDER MEDIUM | Hazleton Research Products, Inc. | 1985-03-07 | Traditional | PDF ↗ |
| K850237 | EBSS W/O CA & MG | Hazleton Research Products, Inc. | 1985-03-07 | Traditional | PDF ↗ |
| K850228 | HAM'S MIXTURE F-10 MEDIUM | Hazleton Research Products, Inc. | 1985-03-07 | Traditional | PDF ↗ |
| K850230 | RPMI-1634 MEDIUM | Hazleton Research Products, Inc. | 1985-03-05 | Traditional | PDF ↗ |
| K850221 | ALPHA MEM W/NUCLEOSIDES POWDER MEDIUM | Hazleton Research Products, Inc. | 1985-03-05 | Traditional | PDF ↗ |
| K850222 | HANKS' MEM W/NON-ESSENTIAL AMINO ACIDS POWDER MED- | Hazleton Research Products, Inc. | 1985-03-05 | Traditional | PDF ↗ |
| K850224 | WAYMOUTH'S MEDIUM MB 752/1 | Hazleton Research Products, Inc. | 1985-03-05 | Traditional | PDF ↗ |
| K850229 | RPMI-1603 MEDIUM | Hazleton Research Products, Inc. | 1985-03-05 | Traditional | PDF ↗ |
| K850510 | EMEM W/NEAA-MINIMUM ESSENTIAL MED. W/NON-ESS. AMIN | Mediatech, Inc. | 1985-03-04 | Traditional | PDF ↗ |
| K845012 | NUTRIENT MIXTURE F-10 -HAM, N 1387, W/L-GLUTAMINE | Sigma Chemical Co. | 1985-02-27 | Traditional | PDF ↗ |
| K845014 | MED. 199 W/EARLE'S SALTS, L-GLUTAMINE & 25MM HEPES | Sigma Chemical Co. | 1985-02-27 | Traditional | PDF ↗ |
| K850091 | BASAL MED. EAGLE(BME) W/EARLE'S SALTS, L-GLUTAMINE | Sigma Chemical Co. | 1985-02-27 | Traditional | PDF ↗ |
| K850518 | NA PYRUVATE-SODIUM PYRUVATE | Mediatech, Inc. | 1985-02-27 | Traditional | PDF ↗ |
| K850520 | NEAA-NON-ESSENTIAL AMINO ACIDS | Mediatech, Inc. | 1985-02-27 | Traditional | PDF ↗ |
| K850517 | MED. 199 W/EARLE'S SALTS-MEDIUM 199 W/EARLES SALTS | Mediatech, Inc. | 1985-02-27 | Traditional | PDF ↗ |
| K845013 | RPMI-1640 MED. W/L-GLUTAMINE & 25MM HEPES & W/O SO | Sigma Chemical Co. | 1985-02-27 | Traditional | PDF ↗ |
| K850089 | MINIMUM ESSENTIAL MED. (MEM) W/EARLE'S SALS L-GLUT | Sigma Chemical Co. | 1985-02-27 | Traditional | PDF ↗ |
| K850511 | EMEM-EARLE'S MINIMUM ESSENTIAL MED. W/GLUTAMINE-EA | Mediatech, Inc. | 1985-02-27 | Traditional | PDF ↗ |
| K850515 | HAM'S F-10-A SPEC. FORMULATION FROM DR. HAM | Mediatech, Inc. | 1985-02-27 | Traditional | PDF ↗ |
| K850526 | EBSS W/O CA & MG-EARLE'S BALANCED SALT SOLUTION | Mediatech, Inc. | 1985-02-27 | Traditional | PDF ↗ |
| K850524 | HBSS-HANKS' BALANCED SALT SOLUTION | Mediatech, Inc. | 1985-02-27 | Traditional | PDF ↗ |
| K850523 | EBSS-EARLE'S BALANCE SALT SOLUTION | Mediatech, Inc. | 1985-02-27 | Traditional | PDF ↗ |
| K850514 | ALPHA MEM-ALPHA MINIMUM ESSENTIAL MED. W/O RIBOSID | Mediatech, Inc. | 1985-02-27 | Traditional | PDF ↗ |
| K850512 | DMEM-DULBECCO'S MINIMUM ESSENTIAL MEDIUM | Mediatech, Inc. | 1985-02-27 | Traditional | PDF ↗ |
| K850092 | DULBECCO'S MODIFIED EAGLE'S MED. (DME) W/GLUCOSE A | Sigma Chemical Co. | 1985-02-27 | Traditional | PDF ↗ |
| K850525 | DPBS-DULBECCO'S PHOSPHATE BUFFERED SALINE | Mediatech, Inc. | 1985-02-27 | Traditional | PDF ↗ |
| K850513 | RPMI 1640-ROSWELL PARK MEMORIAL INSTITUTE 1640 | Mediatech, Inc. | 1985-02-27 | Traditional | PDF ↗ |
| K850522 | MEM VITAMINS-MINIMUM ESSENTIAL MEDIUM VITAMINS | Mediatech, Inc. | 1985-02-27 | Traditional | PDF ↗ |
| K850519 | GLUTAMINE-1-GLUTAMINE | Mediatech, Inc. | 1985-02-27 | Traditional | PDF ↗ |
| K850090 | DULBECCO'S MODIFIED EAGLE'S MED. (DME) W/1000 MG/L | Sigma Chemical Co. | 1985-02-27 | Traditional | PDF ↗ |
| K850516 | HAM'S F-12-A SPEDIFIC FORMULATION FORM DR. HAM | Mediatech, Inc. | 1985-02-27 | Traditional | PDF ↗ |
| K850521 | MEM AA-MINIMUM ESSENTIAL MEDIUM AMINO ACIDS | Mediatech, Inc. | 1985-02-27 | Traditional | PDF ↗ |
| K844288 | INRA MENEZO B2 MEDIA | Fcs Laboratories, Inc. | 1984-12-13 | Traditional | PDF ↗ |
| K843862 | ULTRACLONE ECL-01-900 CELL LINE | Earl-Clay Laboratories, Inc. | 1984-10-17 | Traditional | PDF ↗ |
| K843863 | ULTRACLONE ECL-01-1300 CELL LINE | Earl-Clay Laboratories, Inc. | 1984-10-17 | Traditional | PDF ↗ |
| K843864 | ULTRACLONE ECL-01-1400 CELL LINE | Earl-Clay Laboratories, Inc. | 1984-10-17 | Traditional | PDF ↗ |
| K843086 | DULBECCO'S MODIFIED EAGLE'S NUTIRENT MIX | Sigma Chemical Co. | 1984-08-28 | Traditional | PDF ↗ |
| K843085 | RPMI-1640 MEDIUM #R3505 W/HAT, L-GLUTA | Sigma Chemical Co. | 1984-08-28 | Traditional | PDF ↗ |
| K842776 | MINIMUM ESSENTIAL MED W/L-GLUTAMINE | Sigma Chemical Co. | 1984-08-20 | Traditional | PDF ↗ |
| K842775 | MIN. ESSENTIAL MED. W/L-GLUTAMINE, RIB | Sigma Chemical Co. | 1984-08-17 | Traditional | PDF ↗ |
| K843044 | MINIM. ESSENTIAL MED. EAGLE M4144 W/ | Sigma Chemical Co. | 1984-08-14 | Traditional | PDF ↗ |
| K843043 | MED. 199 CATALOG M3769 W/EARLE'S SALT | Sigma Chemical Co. | 1984-08-14 | Traditional | PDF ↗ |
| K843045 | LACTALBUMIN HYDROLYSATE MED. CATALOG | Sigma Chemical Co. | 1984-08-12 | Traditional | PDF ↗ |
| K842672 | MINIMUM ESSENTIAL MED. M0769 W/WO | Sigma Chemical Co. | 1984-07-20 | Traditional | PDF ↗ |
| K842671 | BASAL MED. EAGLE B8265, W/EARLS SALTS | Sigma Chemical Co. | 1984-07-20 | Traditional | PDF ↗ |
| K841993 | HL-1, DEFINED SERUM FREE MEDIA | Ventrex Laboratories, Inc. | 1984-06-25 | Traditional | PDF ↗ |
| K842002 | HANKS BALANCED SALTS-HBSS H2387 | Sigma Chemical Co. | 1984-06-22 | Traditional | PDF ↗ |
| K840744 | TRANSPORTER VIRAL TRANSPORT MEDIUM | Bartels Immunodiagnostic Supplies, Inc. | 1984-06-07 | Traditional | PDF ↗ |
| K841744 | DULBECCO'S PHOSPHATE BUFFERED SALINE | Sigma Chemical Co. | 1984-05-11 | Traditional | PDF ↗ |
| K834116 | DEAE-DEXTRAN IN PBS | Bartels Immunodiagnostic Supplies, Inc. | 1984-04-20 | Traditional | PDF ↗ |
| K834113 | TISSUE CULTURE REFEEDING MEDIUM | Bartels Immunodiagnostic Supplies, Inc. | 1984-03-23 | Traditional | PDF ↗ |
| K834136 | PBS W/MG+2 & CA+2 | Bartels Immunodiagnostic Supplies, Inc. | 1984-03-22 | Traditional | PDF ↗ |
| K834122 | CHLAMYDIAE ISOLATION MEDIUM W/CYCLOHEX | Bartels Immunodiagnostic Supplies, Inc. | 1984-02-13 | Traditional | PDF ↗ |
| K833389 | MEDIUM 199 W/EARLE'S SALTS W/L-GLUTAM | Sigma Chemical Co. | 1983-11-03 | Traditional | PDF ↗ |
| K833392 | WAYMOUTH MB 752/1 MED. W/L-GLUTAMINE | Sigma Chemical Co. | 1983-11-03 | Traditional | PDF ↗ |
| K833390 | TYRODE'S SALT SOLUTION W/SODIUM BICAR | Sigma Chemical Co. | 1983-11-03 | Traditional | PDF ↗ |
| K833394 | MEDIUM 199 W/HANK'S SALT W/L-GLUTAMINE | Sigma Chemical Co. | 1983-11-03 | Traditional | PDF ↗ |
| K833393 | ISCOE'S MOD. DULBECCO'S MED. W/GLUTAM | Sigma Chemical Co. | 1983-11-03 | Traditional | PDF ↗ |
| K833391 | LACTALBUMIN HYDROLYSATE MED. W/HANKS | Sigma Chemical Co. | 1983-11-03 | Traditional | PDF ↗ |
| K833169 | MEM W/L-GLUTAMINE W/O SODIUM BICARBON | Sigma Chemical Co. | 1983-10-28 | Traditional | PDF ↗ |
| K833168 | MEM-EAGLE-W/EARLES SALTS W/NEAA & | Sigma Chemical Co. | 1983-10-28 | Traditional | PDF ↗ |
| K833165 | FISHERS MED. FOR LEUKEMIC CELLS-MICE | Sigma Chemical Co. | 1983-10-28 | Traditional | PDF ↗ |
Product code KIT · Class I · Hematology. Data: openFDA.