Formulations, Balanced Salt Solutions
FDA product code KIP · Class I (low risk) · 21 CFR 864.2875 · Hematology
17510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K870491 | Krebs-Ringer Bicarbonate Buffer Product No. K4002KIP · Traditional | Sigma Chemical Co. | 03/30/1987SE |
| K870486 | Earle's Balanced Salts (Ebss) Hybri-Max #E9509KIP · Traditional | Sigma Chemical Co. | 03/30/1987SE |
| K870484 | Hanks' Balanced Salts (HBSS) No. H1387KIP · Traditional | Sigma Chemical Co. | 03/30/1987SE |
| K870482 | (D-Pbs) Modified Hybri-Max Product No. D7030KIP · Traditional | Sigma Chemical Co. | 03/30/1987SE |
| K860784 | Dulbecco's Phosphate Buffered Saline W/CALCL2KIP · Traditional | Tissue Culture Innovations | 03/12/1986SE |
| K844878 | Trypsin 10X - 1:250 in HBSS W/O Ca & MGKIP · Traditional | Hazleton Research Products, Inc. | 02/25/1985SE |
| K844877 | Hepes Buffer Im in Normal SalineKIP · Traditional | Hazleton Research Products, Inc. | 02/25/1985SE |
| K842725 | Saline, 0.85%W/PRESERVATIVEKIP · Traditional | E K Ind., Inc. | 08/03/1984SE |
| K842724 | Saline 0.85% W/O PreservativeKIP · Traditional | E K Ind., Inc. | 08/03/1984SE |
| K842723 | Saline, 1.3% W/O PreservativeKIP · Traditional | E K Ind., Inc. | 08/03/1984SE |
| K820928 | Ebs PowderKIP · Traditional | Dutchland Laboratories, Inc. | 04/21/1982SE |
| K820927 | HBS PowderKIP · Traditional | Dutchland Laboratories, Inc. | 04/21/1982SE |
| K820923 | Dulbecco's PBS PowderKIP · Traditional | Dutchland Laboratories, Inc. | 04/21/1982SE |
| K810779 | Earle's Balanced Salts SoultionKIP · Traditional | Dutchland Laboratories, Inc. | 05/13/1981SE |
| K810777 | Hanks' Balanced Salts Solution (Modif.)KIP · Traditional | Dutchland Laboratories, Inc. | 05/08/1981SE |
| K810766 | Hanks' Balanced Salt Solution W/O Ca-MgKIP · Traditional | Dutchland Laboratories, Inc. | 05/08/1981SE |
| K781391 | PBS for Fa (46-991-49)KIP · Traditional | Flow Laboratories, Inc. | 08/21/1978SE |