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 1 of 4
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K892938 | AMNIO-GROW TM | Inovar Biologicals, Inc. | 1989-05-22 | Traditional | PDF ↗ |
| K890700 | MELANOCYTE GROWTH MEDIUM (MGM) | Clonetics Corp. | 1989-02-24 | Traditional | PDF ↗ |
| K890701 | ENDOTHELIAL GROWTH MEDIUM (EGM) | Clonetics Corp. | 1989-02-24 | Traditional | PDF ↗ |
| K890482 | ABC, ABC-1X, ABC(TM) | Cell Ent., Inc. | 1989-02-10 | Traditional | PDF ↗ |
| K884654 | ALPHACALF SERUM | Hyclone Laboratories, Inc. | 1988-11-30 | Traditional | PDF ↗ |
| K884573 | HBSS W/O CALC CHLOR/MAG SULF/PHEN RED/SB NO. H4891 | Sigma Chemical Co. | 1988-11-22 | Traditional | PDF ↗ |
| K884572 | RPMI-1640 HYBRI-MAX, PROD. NO. R5382 | Sigma Chemical Co. | 1988-11-22 | Traditional | PDF ↗ |
| K884574 | DME & HAM'S NUTRIENT MIXTURE, PROD. NO. D9785 | Sigma Chemical Co. | 1988-11-22 | Traditional | PDF ↗ |
| K883065 | ALLOPREP SYSTEM | Osteotech, Inc. | 1988-10-13 | Traditional | PDF ↗ |
| K884031 | FBS, EQ., OR FETAL BOVINE SERUM EQUIVALENT | Regency Biotech | 1988-10-06 | Traditional | PDF ↗ |
| K883951 | MEDIUM 199 W/EBSS (CATALOG NO. 200-2037) | J R Scientific | 1988-09-30 | Traditional | PDF ↗ |
| K883682 | CHANG MEDIUM (ADDITIONAL INDICATIONS) | Hana Biologics, Inc. | 1988-09-16 | Traditional | PDF ↗ |
| K883624 | EX-CELL 300TM, CATALOG NO. 200-3601 | J R Scientific | 1988-09-07 | Traditional | PDF ↗ |
| K883628 | MIN ESSENT MED EAGLE FOR SPINN CULTURE, #200-2051 | J R Scientific | 1988-09-07 | Traditional | PDF ↗ |
| K883626 | EX-CELL 301, CATALOG NO. 210-3577 | J R Scientific | 1988-09-07 | Traditional | PDF ↗ |
| K883632 | EX-CELL 300TM, CATALOG NO. 210-3575 | J R Scientific | 1988-09-07 | Traditional | PDF ↗ |
| K883627 | MIN ESSENT MED EAGLE, JOKLIK MOD, CAT. #200-2150 | J R Scientific | 1988-09-07 | Traditional | PDF ↗ |
| K883623 | EX-CELL 300TM, CATALOG NO. 200-3600 | J R Scientific | 1988-09-07 | Traditional | PDF ↗ |
| K883629 | HANK'S BALANCED SALTS (HBSS) CATALOG # 210-3013 | J R Scientific | 1988-09-07 | Traditional | PDF ↗ |
| K883631 | EX-CELL 300TM, CATALOG # 210-3579 | J R Scientific | 1988-09-07 | Traditional | PDF ↗ |
| K883630 | RPMI-1640 MEDIUM, CATALOG NO. 210-3525 | J R Scientific | 1988-09-07 | Traditional | PDF ↗ |
| K883625 | EX-CELL 301, CATALOG NO. 200-3651 | J R Scientific | 1988-09-07 | Traditional | PDF ↗ |
| K883451 | SFRE 199-1 MEDIUM, CATALOG NO. 200-2191 | J R Scientific | 1988-08-30 | Traditional | PDF ↗ |
| K883446 | FETAL BOVINE SERUM, GAMMA IRRADIATED NO. 110-1122 | J R Scientific | 1988-08-29 | Traditional | PDF ↗ |
| K883368 | NEWBORN CALF SERUM, CATALOG NO. 110-1130 | J R Scientific | 1988-08-29 | Traditional | PDF ↗ |
| K883362 | L-15 MEDIUM, CATALOG NO. 200-2021 | J R Scientific | 1988-08-29 | Traditional | PDF ↗ |
| K883496 | MINIMUM ESSENTIAL MEDIUM EAGLE (MEM), 210-3517 | J R Scientific | 1988-08-29 | Traditional | PDF ↗ |
| K883449 | MINIMUM ESSENTIAL MEDIUM EAGLE, NO. 200-2048 | J R Scientific | 1988-08-29 | Traditional | PDF ↗ |
| K883495 | MEDIUM 199, 10X, CATALOG NO. 210-3555 | J R Scientific | 1988-08-29 | Traditional | PDF ↗ |
| K883497 | MEDIUM 199, 10X CATALOG NO. 210-3556 | J R Scientific | 1988-08-29 | Traditional | PDF ↗ |
| K883370 | FISCHER'S MEDIUM CATALOG NO. 210-4007 | J R Scientific | 1988-08-29 | Traditional | PDF ↗ |
| K883366 | MEDIUM 199, CATALOG NO. 200-2031 | J R Scientific | 1988-08-29 | Traditional | PDF ↗ |
| K883448 | MINIMUM ESSENTIAL MEDIUM EAGLE NO. 200-2046 | J R Scientific | 1988-08-29 | Traditional | PDF ↗ |
| K883365 | HORSE SERUM, ABATTOIR, NO. 110-1112 | J R Scientific | 1988-08-29 | Traditional | PDF ↗ |
| K883502 | FETAL BOVINE SERUM, DEFINED NO. 110-1121 | J R Scientific | 1988-08-29 | Traditional | PDF ↗ |
| K883369 | L-15 MEDIUM, CATALOG NO. 210-4004 | J R Scientific | 1988-08-29 | Traditional | PDF ↗ |
| K883500 | MCCOY'S 5A MEDIUM 10X NO. 210-3532 | J R Scientific | 1988-08-29 | Traditional | PDF ↗ |
| K883499 | MEDIUM 199, 10X, CATALOG NO. 210-3557 | J R Scientific | 1988-08-29 | Traditional | PDF ↗ |
| K883445 | HANKS' BALANCED SALTS (HBSS) 10X, NO. 210-3012 | J R Scientific | 1988-08-29 | Traditional | PDF ↗ |
| K883498 | FETAL BOVINE SERUM, HEAT INACTIVATED NO.110-1123 | J R Scientific | 1988-08-29 | Traditional | PDF ↗ |
| K883364 | ISCOVE'S MODIFIED DELBECCO'S MEDIUM NO.210-3505 | J R Scientific | 1988-08-29 | Traditional | PDF ↗ |
| K883447 | MINIMUM ESSENTIAL MEDIUM EAGLE 10X, NO.210-3511 | J R Scientific | 1988-08-29 | Traditional | PDF ↗ |
| K883367 | CALF SERUM, CATALOG NO. 110-1125 | J R Scientific | 1988-08-29 | Traditional | PDF ↗ |
| K883363 | ISCOVE'S MODIFIED DELBECCO'S MEDIUM NO.200-2105 | J R Scientific | 1988-08-29 | Traditional | PDF ↗ |
| K883501 | MCCOY'S 5A MEDIUM (CATALOG NO. 210-3531) | J R Scientific | 1988-08-29 | Traditional | PDF ↗ |
| K883450 | SFRE 199-2 MEDIUM, CATALOG NO. 200-2192 | J R Scientific | 1988-08-29 | Traditional | PDF ↗ |
| K883141 | RPMI-1640 W/25MM HEPES BUFF W/O SOD BICAR 200-2120 | J R Scientific | 1988-08-15 | Traditional | PDF ↗ |
| K883140 | MINIMUM ESSENTIAL MED (MEM,THERMO-POW(R)#200-2090 | J R Scientific | 1988-08-15 | Traditional | PDF ↗ |
| K883290 | DONOR BOVINE SERUM, CAT. NO. 110-1116 | J R Scientific | 1988-08-15 | Traditional | PDF ↗ |
| K883287 | CALF SERUM, GAMMA IRRADIATED, CAT. NO. 110-1126 | J R Scientific | 1988-08-15 | Traditional | PDF ↗ |
| K883138 | CMRL 1969 MAINTENANCE MEDIUM CAT, # 200-2177 | J R Scientific | 1988-08-15 | Traditional | PDF ↗ |
| K883292 | BOVINE SERUM, CAT. LNO. 110-1115 | J R Scientific | 1988-08-15 | Traditional | PDF ↗ |
| K883285 | FETAL BOVINE SERUM, CAT. NO. 110-1120 | J R Scientific | 1988-08-15 | Traditional | PDF ↗ |
| K883288 | DONOR HORSE SERUM, HEAT INACTIVATED, #110-1113 | J R Scientific | 1988-08-15 | Traditional | PDF ↗ |
| K883286 | NEWBORN CALF SERUM, HEAT INACTIVATED # 110-1131 | J R Scientific | 1988-08-15 | Traditional | PDF ↗ |
| K883291 | DONOR HORSE SERUM, CAT. NO. 110-1110 | J R Scientific | 1988-08-15 | Traditional | PDF ↗ |
| K883289 | CALF SERUM, HEAT INACTIVATED, CAT. # 110-1127 | J R Scientific | 1988-08-15 | Traditional | PDF ↗ |
| K883139 | MEDIUM 199 EBSS/NUTRIENT MIXTURE F-10 #200-2110 | J R Scientific | 1988-08-15 | Traditional | PDF ↗ |
| K882996 | DULBECCO'S PHOSPHATE BUFFERED SALINE NO.210-3022 | J R Scientific | 1988-08-04 | Traditional | PDF ↗ |
| K882990 | RPMI-1640 BAKER'S MODIFICATION NO. 200-2078 | J R Scientific | 1988-08-04 | Traditional | PDF ↗ |
| K882989 | DULBECCO'S MODIFIED EAGLE'S MEDIUM NO. 210-3502 | J R Scientific | 1988-08-04 | Traditional | PDF ↗ |
| K882988 | DULBECCO'S MODIFIED EAGLE'S MEDIUM NO. 210-3540 | J R Scientific | 1988-08-04 | Traditional | PDF ↗ |
| K882997 | (DME/F-12 1:1), CATALOG NO. 200-2100 | J R Scientific | 1988-08-04 | Traditional | PDF ↗ |
| K882965 | KREBS-HENSELEIT BICARBONATE BUFFER NO. K3753 | Sigma Chemical Co. | 1988-08-04 | Traditional | PDF ↗ |
| K882993 | NUTRIENT MIXTURE F-12 (HAM) NO. 200-2071 | J R Scientific | 1988-08-04 | Traditional | PDF ↗ |
| K882987 | DULBECCO'S MODIFIED EAGLE'S MEDIUM NO. 200-2009 | J R Scientific | 1988-08-04 | Traditional | PDF ↗ |
| K882983 | MEDIUM 199, CATALOG NO. 210-3535 | J R Scientific | 1988-08-04 | Traditional | PDF ↗ |
| K882986 | MCCOY'S 5A MEDIUM NO. 210-3530 | J R Scientific | 1988-08-04 | Traditional | PDF ↗ |
| K882985 | FISCHER'S MEDIUM NO. 200-2184 | J R Scientific | 1988-08-04 | Traditional | PDF ↗ |
| K882991 | NUTRIENT MIXTURE F-12 (HAT VARIATION) NO. 200-2070 | J R Scientific | 1988-08-04 | Traditional | PDF ↗ |
| K882992 | MINIMUM ESSENTIAL MEDIUM, ALPHA MODI. NO.200-2091 | J R Scientific | 1988-08-04 | Traditional | PDF ↗ |
| K882994 | DULBECCO'S PHOSPHATE BUFFERED SALINE NO. 210-3021 | J R Scientific | 1988-08-04 | Traditional | PDF ↗ |
| K882995 | FISCHER'S MEDIUM NO. 200-2188 | J R Scientific | 1988-08-04 | Traditional | PDF ↗ |
| K882984 | MEDIUM 199, NO. 200-2035 | J R Scientific | 1988-08-04 | Traditional | PDF ↗ |
| K882837 | DULBECCO'S MODIFIED EAGLE'S MEDIUM, NO. 200-2183 | J R Scientific | 1988-08-01 | Traditional | PDF ↗ |
| K882848 | RPMI-1640 MEDIUM, CATALOG NO. 210-3521 | J R Scientific | 1988-08-01 | Traditional | PDF ↗ |
| K882854 | MEDIUM 199, CATALOG NO. 210-3536 | J R Scientific | 1988-08-01 | Traditional | PDF ↗ |
| K882851 | RPMI-1640 MEDIUM, CATALOG NO. 210-3523 | J R Scientific | 1988-08-01 | Traditional | PDF ↗ |
| K882846 | DULBECCO'S MODIFIED EAGLE'S MEDIUM NO. 210-3501 | J R Scientific | 1988-08-01 | Traditional | PDF ↗ |
| K882850 | NUTRIENT MIXTURE F-10 (HAM) NO. 210-3550 | J R Scientific | 1988-08-01 | Traditional | PDF ↗ |
| K882847 | MINIMUM ESSENTIAL MEDIUM EAGLE NO. 210-3515 | J R Scientific | 1988-08-01 | Traditional | PDF ↗ |
| K882849 | DULBECCO'S MODIFIED EAGLE'S MEDIUM NO. 210-3500 | J R Scientific | 1988-08-01 | Traditional | PDF ↗ |
| K882861 | MINIMUM ESSENTIAL MEDIUM EAGLE NO. 210-3514 | J R Scientific | 1988-08-01 | Traditional | PDF ↗ |
| K882853 | RPMI-1640 MEDIUM, CATALOG NO. 210-3520 | J R Scientific | 1988-08-01 | Traditional | PDF ↗ |
| K882863 | MINIMUM ESSENTIAL MEDIUM EAGLE (MEM) NO. 210-3512 | J R Scientific | 1988-08-01 | Traditional | PDF ↗ |
| K882860 | MINIMUM ESSENTIAL MEDIUM EAGLE NO. 210-3510 | J R Scientific | 1988-08-01 | Traditional | PDF ↗ |
| K882856 | EARLE'S BALANCED SALT SOLUTION NO. 210-3005 | J R Scientific | 1988-07-28 | Traditional | PDF ↗ |
| K882857 | HANKS' BALANCED SALTS NO. 210-3010 | J R Scientific | 1988-07-28 | Traditional | PDF ↗ |
| K882865 | DULBECCO'S PHOSPHATE BUFFERED SALINE NO. 210-3025 | J R Scientific | 1988-07-28 | Traditional | PDF ↗ |
| K882842 | EARLE'S BALANCED SALTS (EBSS) NO. 200-2505 | J R Scientific | 1988-07-28 | Traditional | PDF ↗ |
| K882858 | NUTRIENT MIXTURE F-12 (HAM), NO. 210-3551 | J R Scientific | 1988-07-28 | Traditional | PDF ↗ |
| K882864 | HANKS' BALANCED SALT SOLUTION (HBSS) NO. 210-3011 | J R Scientific | 1988-07-28 | Traditional | PDF ↗ |
| K882839 | EARLE'S BALANCED SALTS (EBSS) NO. 200-2506 | J R Scientific | 1988-07-28 | Traditional | PDF ↗ |
| K882862 | DULBECCO'S PHOSPHATE BUFFERED SALINE NO. 200-2530 | J R Scientific | 1988-07-28 | Traditional | PDF ↗ |
| K882840 | HANK'S BALANCED SALTS (HBSS) NO. 200-2520 | J R Scientific | 1988-07-28 | Traditional | PDF ↗ |
| K882859 | DULBECCO'S PHOSPHATE BUFFERED SALINE NO. 210-3020 | J R Scientific | 1988-07-28 | Traditional | PDF ↗ |
| K882866 | EARLE'S BALANCED SALT SOLUTION (EBSS) NO. 210-3000 | J R Scientific | 1988-07-28 | Traditional | PDF ↗ |
| K882844 | HANK'S BALANCED SALTS NO. 200-2510 | J R Scientific | 1988-07-28 | Traditional | PDF ↗ |
| K882852 | DULBECCO'S PHOSPHATE BUFFERED SALINE, NO 200-2525 | J R Scientific | 1988-07-28 | Traditional | PDF ↗ |
| K882843 | HANK'S BALANCED SALTS NO. 200-2515 | J R Scientific | 1988-07-28 | Traditional | PDF ↗ |
Product code KIT · Class I · Hematology. Data: openFDA.