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 4 of 4
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K833163 | MEM-EAGLE W/EARLES SALTS W/IVEAA | Sigma Chemical Co. | 1983-10-28 | Traditional | PDF ↗ |
| K833164 | L-15-LEIBOVITZ W/L-GLUTAMINE-L4386 | Sigma Chemical Co. | 1983-10-27 | Traditional | PDF ↗ |
| K833016 | TISSUE TRANSPORT MEDIUM | Northern Scientific, Inc. | 1983-10-14 | Traditional | PDF ↗ |
| K832835 | DULBECCOS PHOSPHATE BUFFERED SALINE | Sigma Chemical Co. | 1983-09-29 | Traditional | PDF ↗ |
| K832841 | NUTRIENT MIXTURE F12 #N6760 W/L-GLUTAM | Sigma Chemical Co. | 1983-09-29 | Traditional | PDF ↗ |
| K832930 | SPINNER SALT SOLUTION S-6011 W/EARLES | Sigma Chemical Co. | 1983-09-29 | Traditional | PDF ↗ |
| K832842 | DULBECCOS MODIFIED EAGLES MEDIUM D5648 | Sigma Chemical Co. | 1983-09-29 | Traditional | PDF ↗ |
| K832836 | BASAL MED. #B9763 W/HANKS SALTS W/L-G | Sigma Chemical Co. | 1983-09-29 | Traditional | PDF ↗ |
| K832838 | EARLES BALANCED SALT MIXTURE #E6132 | Sigma Chemical Co. | 1983-09-26 | Traditional | PDF ↗ |
| K832837 | NUTRIENT MIXTURE F-10 #N6635 W/L-GLUTA | Sigma Chemical Co. | 1983-09-26 | Traditional | PDF ↗ |
| K832840 | MINIMUM ESSENTIAL MED. EAGLE M4642 W/ | Sigma Chemical Co. | 1983-09-26 | Traditional | PDF ↗ |
| K832839 | HANKS BALANCED SALT MIXTURE H6136 | Sigma Chemical Co. | 1983-09-26 | Traditional | PDF ↗ |
| K832687 | BASAL MED. EAGLE #B9888 W/L-GLUTAMINE | Sigma Chemical Co. | 1983-09-12 | Traditional | PDF ↗ |
| K832688 | DULBECCO'S MODIFIED EAGLE #D5523- | Sigma Chemical Co. | 1983-09-12 | Traditional | PDF ↗ |
| K832689 | MCCOY'S 5A #M4892 W/L-GLUTAMINE AND | Sigma Chemical Co. | 1983-09-12 | Traditional | PDF ↗ |
| K832690 | MINIMUM ESSENTIAL MED. EAGLE M0268 | Sigma Chemical Co. | 1983-09-12 | Traditional | PDF ↗ |
| K831686 | CHLAMYDIA OVERBY MEDIA | Viromed Laboratories, Inc. | 1983-07-07 | Traditional | PDF ↗ |
| K831745 | BASAL MEDIUM EAGLE W/EARLES SALTS, & | Sigma Chemical Co. | 1983-07-06 | Traditional | PDF ↗ |
| K831685 | SF REFEEDING MEDIA | Viromed Laboratories, Inc. | 1983-07-06 | Traditional | PDF ↗ |
| K831519 | RPMI-1640 MEDIUM W/L-GLUTAMINE & | Sigma Chemical Co. | 1983-06-22 | Traditional | PDF ↗ |
| K821911 | S-MEM-JOKLIK'S POWDER | Dutchland Laboratories, Inc. | 1982-07-27 | Traditional | PDF ↗ |
| K821913 | ISCOVE'S MODIFIED DULBECCO POWDER MEDIUM | Dutchland Laboratories, Inc. | 1982-07-27 | Traditional | PDF ↗ |
| K821916 | IMPROVED MEM-RICHTER'S POWDER MODIF. | Dutchland Laboratories, Inc. | 1982-07-27 | Traditional | PDF ↗ |
| K821917 | WAYMOUTH'S POWDER MEDIUM | Dutchland Laboratories, Inc. | 1982-07-27 | Traditional | PDF ↗ |
| K821915 | BME AUTOCLAVABLE MEDIUM | Dutchland Laboratories, Inc. | 1982-07-27 | Traditional | PDF ↗ |
| K821918 | POWDERED RPMI-1603 MEDIUM | Dutchland Laboratories, Inc. | 1982-07-27 | Traditional | PDF ↗ |
| K821914 | COON'S F-12 POWDER MEDIUM | Dutchland Laboratories, Inc. | 1982-07-27 | Traditional | PDF ↗ |
| K821919 | POWDERED RPMI-1634 MEDIUM | Dutchland Laboratories, Inc. | 1982-07-27 | Traditional | PDF ↗ |
| K821912 | MCCOY'S POWDER MEDIUM 5A SUSPENSION | Dutchland Laboratories, Inc. | 1982-07-27 | Traditional | PDF ↗ |
| K820920 | MCCOY'S 5A POWDERED MEDIUM | Dutchland Laboratories, Inc. | 1982-04-21 | Traditional | PDF ↗ |
| K820924 | HAMS F-12 POWDERED MEDIUM | Dutchland Laboratories, Inc. | 1982-04-21 | Traditional | PDF ↗ |
| K820926 | E-BME POWDERED MEDIUM | Dutchland Laboratories, Inc. | 1982-04-21 | Traditional | PDF ↗ |
| K820917 | L-15 POWDERED MEDIUM | Dutchland Laboratories, Inc. | 1982-04-21 | Traditional | PDF ↗ |
| K820925 | H - BME POWDERED MEDIUM | Dutchland Laboratories, Inc. | 1982-04-21 | Traditional | PDF ↗ |
| K820922 | HAMS F-10 POWDERED MEDIUM | Dutchland Laboratories, Inc. | 1982-04-21 | Traditional | PDF ↗ |
| K820929 | RPMI-164POWDERED MEDIUM | Dutchland Laboratories, Inc. | 1982-04-21 | Traditional | PDF ↗ |
| K820915 | MEM AUTOCLAVABLE MEDIUM | Dutchland Laboratories, Inc. | 1982-04-21 | Traditional | PDF ↗ |
| K820931 | HANK'S 199 POWDERED MEDIUM | Dutchland Laboratories, Inc. | 1982-04-21 | Traditional | PDF ↗ |
| K820930 | FISCHER'S POWDERED MEDIUM | Dutchland Laboratories, Inc. | 1982-04-21 | Traditional | PDF ↗ |
| K820919 | EARLE'S-199 POWDERED MEDIUM | Dutchland Laboratories, Inc. | 1982-04-21 | Traditional | PDF ↗ |
| K820921 | D-MEM-LOW GLUCOSE-POWDERED MEDIUM | Dutchland Laboratories, Inc. | 1982-04-21 | Traditional | PDF ↗ |
| K820918 | HMEM POWDERED MEDIUM | Dutchland Laboratories, Inc. | 1982-04-21 | Traditional | PDF ↗ |
| K820916 | D-MEM-HIGH GLUCOSE-POWDERED MEDIUM | Dutchland Laboratories, Inc. | 1982-04-21 | Traditional | PDF ↗ |
| K820914 | EMEM POWERED MEDIUM | Dutchland Laboratories, Inc. | 1982-04-21 | Traditional | PDF ↗ |
| K820509 | MEM VITAMINS (100X | Dutchland Laboratories, Inc. | 1982-04-08 | Traditional | PDF ↗ |
| K820508 | MEM NON-ESSENTIAL AMINO ACIDS (100X) | Dutchland Laboratories, Inc. | 1982-03-26 | Traditional | PDF ↗ |
| K820495 | SODIUM PYRUVATE (100MM) | Dutchland Laboratories, Inc. | 1982-03-26 | Traditional | PDF ↗ |
| K812885 | DULBECCO MINIMUM ESSENTIAL MED NO GLUTAM | Dutchland Laboratories, Inc. | 1981-11-24 | Traditional | PDF ↗ |
| K812820 | CHANG MEDIUM | Hana Biologics, Inc. | 1981-11-10 | Traditional | PDF ↗ |
| K812531 | CELL CULTURE REAGENTS | M.A. Bioproducts | 1981-10-23 | Traditional | PDF ↗ |
| K812617 | VITROGEN TM 100 | Collagen Corp. | 1981-10-02 | Traditional | PDF ↗ |
| K810772 | MEDIUM 199 W/EARLE'S SALTS & GLUTAMINE | Dutchland Laboratories, Inc. | 1981-05-13 | Traditional | PDF ↗ |
| K810773 | BASAL MEDIUM EAGLE W/HANKS' SALTS | Dutchland Laboratories, Inc. | 1981-05-13 | Traditional | PDF ↗ |
| K810778 | BASAL MEDIUM EAGLE (MOD.) W/EARLE'S SALT | Dutchland Laboratories, Inc. | 1981-05-13 | Traditional | PDF ↗ |
| K810770 | MED. 199(MODIFIED) W/HANKS' SALTS | Dutchland Laboratories, Inc. | 1981-05-13 | Traditional | PDF ↗ |
| K810780 | SODIUM BICARBONATE (7.5%) SOLUTION | Dutchland Laboratories, Inc. | 1981-05-13 | Traditional | PDF ↗ |
| K810771 | L-15 MEDIUM (MODIFIED) | Dutchland Laboratories, Inc. | 1981-05-13 | Traditional | PDF ↗ |
| K810769 | MINIMUM ESSENTIAL MEDIUM EAGLE W/EARLE | Dutchland Laboratories, Inc. | 1981-05-13 | Traditional | PDF ↗ |
| K810781 | L-GLUTAMINE | Dutchland Laboratories, Inc. | 1981-05-13 | Traditional | PDF ↗ |
| K810776 | PENICILLIN-STREPTOMYCIN MIXTURE | Dutchland Laboratories, Inc. | 1981-05-13 | Traditional | PDF ↗ |
| K810783 | ALSEVER'S SOLUTION (MODIFIED) | Dutchland Laboratories, Inc. | 1981-05-13 | Traditional | PDF ↗ |
| K810768 | MINIMUM ESSENTIAL MEDIUM EAGLE W/HANKS | Dutchland Laboratories, Inc. | 1981-05-13 | Traditional | PDF ↗ |
| K810774 | WATER-TISSUE CULTURE GRADE | Dutchland Laboratories, Inc. | 1981-05-13 | Traditional | PDF ↗ |
| K810767 | RPMI 1640 MEDIUM | Dutchland Laboratories, Inc. | 1981-05-08 | Traditional | PDF ↗ |
| K810784 | FUNGIZONE | Dutchland Laboratories, Inc. | 1981-03-23 | Traditional | PDF ↗ |
| K803041 | SERUM FREE TISSUE CULTURE MEDIA | Cartaya Assoc. | 1980-12-30 | Traditional | PDF ↗ |
| K770764 | TISSUE CULTURE MEDIA W/HEPES BUFFER | Microbiological Assoc. | 1977-07-21 | Traditional | PDF ↗ |
Product code KIT · Class I · Hematology. Data: openFDA.