Panels › Hematology › Product code KIT · Class 1
Media And Components, Synthetic Cell And Tissue Culture
Regulation 864.2220
0510(k)s in 12 months (367 all time)
0recalls in 12 months (4 all time)
0recalls that name a 510(k)
Top companies in KIT
| Company | 510(k)s | Recalls |
|---|---|---|
| J R Scientific | 132 | 0 |
| Sigma Chemical Co. | 87 | 0 |
| Dutchland Laboratories, Inc. | 42 | 0 |
| Hazleton Research Products, Inc. | 34 | 0 |
| Mediatech, Inc. | 23 | 0 |
| Bartels Immunodiagnostic Supplies, Inc. | 5 | 0 |
| Tissue Culture Innovations | 5 | 0 |
| Clonetics Corp. | 4 | 0 |
| Life Technologies, Corp. | 0 | 4 |
| Bioclinical Laboratory Services, Inc. | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 27, 1985 | K850523 | EBSS-EARLE'S BALANCE SALT SOLUTION Mediatech, Inc. | KIT |
| Feb 27, 1985 | K850522 | MEM VITAMINS-MINIMUM ESSENTIAL MEDIUM VITAMINS Mediatech, Inc. | KIT |
| Feb 27, 1985 | K850521 | MEM AA-MINIMUM ESSENTIAL MEDIUM AMINO ACIDS Mediatech, Inc. | KIT |
| Feb 27, 1985 | K850520 | NEAA-NON-ESSENTIAL AMINO ACIDS Mediatech, Inc. | KIT |
| Feb 27, 1985 | K850519 | GLUTAMINE-1-GLUTAMINE Mediatech, Inc. | KIT |
| Feb 27, 1985 | K850518 | NA PYRUVATE-SODIUM PYRUVATE Mediatech, Inc. | KIT |
| Feb 27, 1985 | K850517 | MED. 199 W/EARLE'S SALTS-MEDIUM 199 W/EARLES SALTS Mediatech, Inc. | KIT |
| Feb 27, 1985 | K850516 | HAM'S F-12-A SPEDIFIC FORMULATION FORM DR. HAM Mediatech, Inc. | KIT |
| Feb 27, 1985 | K850515 | HAM'S F-10-A SPEC. FORMULATION FROM DR. HAM Mediatech, Inc. | KIT |
| Feb 27, 1985 | K850514 | ALPHA MEM-ALPHA MINIMUM ESSENTIAL MED. W/O RIBOSID Mediatech, Inc. | KIT |
| Feb 27, 1985 | K850513 | RPMI 1640-ROSWELL PARK MEMORIAL INSTITUTE 1640 Mediatech, Inc. | KIT |
| Feb 27, 1985 | K850512 | DMEM-DULBECCO'S MINIMUM ESSENTIAL MEDIUM Mediatech, Inc. | KIT |
| Feb 27, 1985 | K850511 | EMEM-EARLE'S MINIMUM ESSENTIAL MED. W/GLUTAMINE-EA Mediatech, Inc. | KIT |
| Feb 27, 1985 | K850092 | DULBECCO'S MODIFIED EAGLE'S MED. (DME) W/GLUCOSE A Sigma Chemical Co. | KIT |
| Feb 27, 1985 | K850091 | BASAL MED. EAGLE(BME) W/EARLE'S SALTS, L-GLUTAMINE Sigma Chemical Co. | KIT |
| Feb 27, 1985 | K850090 | DULBECCO'S MODIFIED EAGLE'S MED. (DME) W/1000 MG/L Sigma Chemical Co. | KIT |
| Feb 27, 1985 | K850089 | MINIMUM ESSENTIAL MED. (MEM) W/EARLE'S SALS L-GLUT Sigma Chemical Co. | KIT |
| Feb 27, 1985 | K845014 | MED. 199 W/EARLE'S SALTS, L-GLUTAMINE & 25MM HEPES Sigma Chemical Co. | KIT |
| Feb 27, 1985 | K845013 | RPMI-1640 MED. W/L-GLUTAMINE & 25MM HEPES & W/O SO Sigma Chemical Co. | KIT |
| Feb 27, 1985 | K845012 | NUTRIENT MIXTURE F-10 -HAM, N 1387, W/L-GLUTAMINE Sigma Chemical Co. | KIT |
| Dec 13, 1984 | K844288 | INRA MENEZO B2 MEDIA Fcs Laboratories, Inc. | KIT |
| Oct 17, 1984 | K843864 | ULTRACLONE ECL-01-1400 CELL LINE Earl-Clay Laboratories, Inc. | KIT |
| Oct 17, 1984 | K843863 | ULTRACLONE ECL-01-1300 CELL LINE Earl-Clay Laboratories, Inc. | KIT |
| Oct 17, 1984 | K843862 | ULTRACLONE ECL-01-900 CELL LINE Earl-Clay Laboratories, Inc. | KIT |
| Aug 28, 1984 | K843086 | DULBECCO'S MODIFIED EAGLE'S NUTIRENT MIX Sigma Chemical Co. | KIT |
| Aug 28, 1984 | K843085 | RPMI-1640 MEDIUM #R3505 W/HAT, L-GLUTA Sigma Chemical Co. | KIT |
| Aug 20, 1984 | K842776 | MINIMUM ESSENTIAL MED W/L-GLUTAMINE Sigma Chemical Co. | KIT |
| Aug 17, 1984 | K842775 | MIN. ESSENTIAL MED. W/L-GLUTAMINE, RIB Sigma Chemical Co. | KIT |
| Aug 14, 1984 | K843044 | MINIM. ESSENTIAL MED. EAGLE M4144 W/ Sigma Chemical Co. | KIT |
| Aug 14, 1984 | K843043 | MED. 199 CATALOG M3769 W/EARLE'S SALT Sigma Chemical Co. | KIT |
| Aug 12, 1984 | K843045 | LACTALBUMIN HYDROLYSATE MED. CATALOG Sigma Chemical Co. | KIT |
| Jul 20, 1984 | K842672 | MINIMUM ESSENTIAL MED. M0769 W/WO Sigma Chemical Co. | KIT |
| Jul 20, 1984 | K842671 | BASAL MED. EAGLE B8265, W/EARLS SALTS Sigma Chemical Co. | KIT |
| Jun 25, 1984 | K841993 | HL-1, DEFINED SERUM FREE MEDIA Ventrex Laboratories, Inc. | KIT |
| Jun 22, 1984 | K842002 | HANKS BALANCED SALTS-HBSS H2387 Sigma Chemical Co. | KIT |
| Jun 7, 1984 | K840744 | TRANSPORTER VIRAL TRANSPORT MEDIUM Bartels Immunodiagnostic Supplies, Inc. | KIT |
| May 11, 1984 | K841744 | DULBECCO'S PHOSPHATE BUFFERED SALINE Sigma Chemical Co. | KIT |
| Apr 20, 1984 | K834116 | DEAE-DEXTRAN IN PBS Bartels Immunodiagnostic Supplies, Inc. | KIT |
| Mar 23, 1984 | K834113 | TISSUE CULTURE REFEEDING MEDIUM Bartels Immunodiagnostic Supplies, Inc. | KIT |
| Mar 22, 1984 | K834136 | PBS W/MG+2 & CA+2 Bartels Immunodiagnostic Supplies, Inc. | KIT |
| Feb 13, 1984 | K834122 | CHLAMYDIAE ISOLATION MEDIUM W/CYCLOHEX Bartels Immunodiagnostic Supplies, Inc. | KIT |
| Nov 3, 1983 | K833394 | MEDIUM 199 W/HANK'S SALT W/L-GLUTAMINE Sigma Chemical Co. | KIT |
| Nov 3, 1983 | K833393 | ISCOE'S MOD. DULBECCO'S MED. W/GLUTAM Sigma Chemical Co. | KIT |
| Nov 3, 1983 | K833392 | WAYMOUTH MB 752/1 MED. W/L-GLUTAMINE Sigma Chemical Co. | KIT |
| Nov 3, 1983 | K833391 | LACTALBUMIN HYDROLYSATE MED. W/HANKS Sigma Chemical Co. | KIT |
| Nov 3, 1983 | K833390 | TYRODE'S SALT SOLUTION W/SODIUM BICAR Sigma Chemical Co. | KIT |
| Nov 3, 1983 | K833389 | MEDIUM 199 W/EARLE'S SALTS W/L-GLUTAM Sigma Chemical Co. | KIT |
| Oct 28, 1983 | K833169 | MEM W/L-GLUTAMINE W/O SODIUM BICARBON Sigma Chemical Co. | KIT |
| Oct 28, 1983 | K833168 | MEM-EAGLE-W/EARLES SALTS W/NEAA & Sigma Chemical Co. | KIT |
| Oct 28, 1983 | K833165 | FISHERS MED. FOR LEUKEMIC CELLS-MICE Sigma Chemical Co. | KIT |
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