Formulations, Balanced Salt Solutions
Balanced Salt Solution Formulations are physiologically compatible aqueous solutions containing specific concentrations of salts such as sodium chloride, potassium chloride, calcium chloride, and other electrolytes, used in laboratory settings as diluents, washing solutions, and cell suspension media in hematological and tissue culture applications. It is classified as FDA Class 1, the lowest risk category, subject to general controls only, meaning it does not require premarket notification or approval. The product code is KIP, regulated under 21 CFR 864.2875, within the Hematology medical specialty.
Basic Information
- Product Code
- KIP
- Device Class
- FDA class 1
- Regulation Number
- 864.2875
- Medical Specialty
- Hematology
- Review Panel
- PA
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 17 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K870491 | KREBS-RINGER BICARBONATE BUFFER PRODUCT NO. K4002 | Mar 30, 1987 | Substantially Equivalent | SIGMA CHEMICAL CO. |
| K870486 | EARLE'S BALANCED SALTS (EBSS) HYBRI-MAX #E9509 | Mar 30, 1987 | Substantially Equivalent | SIGMA CHEMICAL CO. |
| K870484 | HANKS' BALANCED SALTS (HBSS) NO. H1387 | Mar 30, 1987 | Substantially Equivalent | SIGMA CHEMICAL CO. |
| K870482 | (D-PBS) MODIFIED HYBRI-MAX PRODUCT NO. D7030 | Mar 30, 1987 | Substantially Equivalent | SIGMA CHEMICAL CO. |
| K860784 | DULBECCO'S PHOSPHATE BUFFERED SALINE W/CALCL2 | Mar 12, 1986 | Substantially Equivalent | TISSUE CULTURE INNOVATIONS |
| K844878 | TRYPSIN 10X - 1:250 IN HBSS W/O CA & MG | Feb 25, 1985 | Substantially Equivalent | HAZLETON RESEARCH PRODUCTS, INC. |
| K844877 | HEPES BUFFER IM IN NORMAL SALINE | Feb 25, 1985 | Substantially Equivalent | HAZLETON RESEARCH PRODUCTS, INC. |
| K842725 | SALINE, 0.85%W/PRESERVATIVE | Aug 03, 1984 | Substantially Equivalent | E K IND., INC. |
| K842724 | SALINE 0.85% W/O PRESERVATIVE | Aug 03, 1984 | Substantially Equivalent | E K IND., INC. |
| K842723 | SALINE, 1.3% W/O PRESERVATIVE | Aug 03, 1984 | Substantially Equivalent | E K IND., INC. |
| K820928 | EBS POWDER | Apr 21, 1982 | Substantially Equivalent | DUTCHLAND LABORATORIES, INC. |
| K820927 | HBS POWDER | Apr 21, 1982 | Substantially Equivalent | DUTCHLAND LABORATORIES, INC. |
| K820923 | DULBECCO'S PBS POWDER | Apr 21, 1982 | Substantially Equivalent | DUTCHLAND LABORATORIES, INC. |
| K810779 | EARLE'S BALANCED SALTS SOULTION | May 13, 1981 | Substantially Equivalent | DUTCHLAND LABORATORIES, INC. |
| K810777 | HANKS' BALANCED SALTS SOLUTION (MODIF.) | May 08, 1981 | Substantially Equivalent | DUTCHLAND LABORATORIES, INC. |
| K810766 | HANKS' BALANCED SALT SOLUTION W/O CA-MG | May 08, 1981 | Substantially Equivalent | DUTCHLAND LABORATORIES, INC. |
| K781391 | PBS FOR FA (46-991-49) | Aug 21, 1978 | Substantially Equivalent | FLOW LABORATORIES, INC. |
FEI Numbers
This FDA classification entry is associated with 21 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 21 registration numbers. Click on an entry to view related FDA registrations.