KIP · Formulations, Balanced Salt Solutions
Hematology · 21 CFR 864.2875 · Class 1
Overview
| Product Code | KIP |
|---|---|
| Device Name | Formulations, Balanced Salt Solutions |
| Regulation | 21 CFR 864.2875 |
| Device Class | Class 1 |
| Review Panel | Hematology |
Identification
A balanced salt solution or formulation is a defined mixture of salts and glucose in a simple medium. This device is included as a necessary component of most cell culture systems. This media component controls for pH, osmotic pressure, energy source, and inorganic ions.
Classification Rationale
Class I (general controls). These devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Recent Cleared Devices (17 of 17)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K870491 | KREBS-RINGER BICARBONATE BUFFER PRODUCT NO. K4002 | Sigma Chemical Co. | Mar 30, 1987 | SESE |
| K870486 | EARLE'S BALANCED SALTS (EBSS) HYBRI-MAX #E9509 | Sigma Chemical Co. | Mar 30, 1987 | SESE |
| K870484 | HANKS' BALANCED SALTS (HBSS) NO. H1387 | Sigma Chemical Co. | Mar 30, 1987 | SESE |
| K870482 | (D-PBS) MODIFIED HYBRI-MAX PRODUCT NO. D7030 | Sigma Chemical Co. | Mar 30, 1987 | SESE |
| K860784 | DULBECCO'S PHOSPHATE BUFFERED SALINE W/CALCL2 | Tissue Culture Innovations | Mar 12, 1986 | SESE |
| K844878 | TRYPSIN 10X - 1:250 IN HBSS W/O CA & MG | Hazleton Research Products, Inc. | Feb 25, 1985 | SESE |
| K844877 | HEPES BUFFER IM IN NORMAL SALINE | Hazleton Research Products, Inc. | Feb 25, 1985 | SESE |
| K842725 | SALINE, 0.85%W/PRESERVATIVE | E K Ind., Inc. | Aug 3, 1984 | SESE |
| K842724 | SALINE 0.85% W/O PRESERVATIVE | E K Ind., Inc. | Aug 3, 1984 | SESE |
| K842723 | SALINE, 1.3% W/O PRESERVATIVE | E K Ind., Inc. | Aug 3, 1984 | SESE |
| K820928 | EBS POWDER | Dutchland Laboratories, Inc. | Apr 21, 1982 | SESE |
| K820927 | HBS POWDER | Dutchland Laboratories, Inc. | Apr 21, 1982 | SESE |
| K820923 | DULBECCO'S PBS POWDER | Dutchland Laboratories, Inc. | Apr 21, 1982 | SESE |
| K810779 | EARLE'S BALANCED SALTS SOULTION | Dutchland Laboratories, Inc. | May 13, 1981 | SESE |
| K810777 | HANKS' BALANCED SALTS SOLUTION (MODIF.) | Dutchland Laboratories, Inc. | May 8, 1981 | SESE |
| K810766 | HANKS' BALANCED SALT SOLUTION W/O CA-MG | Dutchland Laboratories, Inc. | May 8, 1981 | SESE |
| K781391 | PBS FOR FA (46-991-49) | Flow Laboratories, Inc. | Aug 21, 1978 | SESE |
Top Applicants
- Dutchland Laboratories, Inc. — 6 clearances
- Sigma Chemical Co. — 4 clearances
- E K Ind., Inc. — 3 clearances
- Hazleton Research Products, Inc. — 2 clearances
- Flow Laboratories, Inc. — 1 clearance
