Browse hierarchy: [Hematology (HE)](/submissions/HE) → [Subpart C — Cell And Tissue Culture Products](/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products) → [21 CFR 864.2875](/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/864.2875) → KIP — Formulations, Balanced Salt Solutions # KIP · Formulations, Balanced Salt Solutions _Hematology · 21 CFR 864.2875 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KIP ## Overview - **Product Code:** KIP - **Device Name:** Formulations, Balanced Salt Solutions - **Regulation:** [21 CFR 864.2875](/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/864.2875) - **Device Class:** 1 - **Review Panel:** [Hematology](/submissions/HE) ## 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](https://fda.innolitics.com/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KIP/K870491.md) | KREBS-RINGER BICARBONATE BUFFER PRODUCT NO. K4002 | Sigma Chemical Co. | Mar 30, 1987 | SESE | | [K870486](https://fda.innolitics.com/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KIP/K870486.md) | EARLE'S BALANCED SALTS (EBSS) HYBRI-MAX #E9509 | Sigma Chemical Co. | Mar 30, 1987 | SESE | | [K870484](https://fda.innolitics.com/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KIP/K870484.md) | HANKS' BALANCED SALTS (HBSS) NO. H1387 | Sigma Chemical Co. | Mar 30, 1987 | SESE | | [K870482](https://fda.innolitics.com/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KIP/K870482.md) | (D-PBS) MODIFIED HYBRI-MAX PRODUCT NO. D7030 | Sigma Chemical Co. | Mar 30, 1987 | SESE | | [K860784](https://fda.innolitics.com/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KIP/K860784.md) | DULBECCO'S PHOSPHATE BUFFERED SALINE W/CALCL2 | Tissue Culture Innovations | Mar 12, 1986 | SESE | | [K844878](https://fda.innolitics.com/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KIP/K844878.md) | TRYPSIN 10X - 1:250 IN HBSS W/O CA & MG | Hazleton Research Products, Inc. | Feb 25, 1985 | SESE | | [K844877](https://fda.innolitics.com/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KIP/K844877.md) | HEPES BUFFER IM IN NORMAL SALINE | Hazleton Research Products, Inc. | Feb 25, 1985 | SESE | | [K842725](https://fda.innolitics.com/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KIP/K842725.md) | SALINE, 0.85%W/PRESERVATIVE | E K Ind., Inc. | Aug 3, 1984 | SESE | | [K842724](https://fda.innolitics.com/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KIP/K842724.md) | SALINE 0.85% W/O PRESERVATIVE | E K Ind., Inc. | Aug 3, 1984 | SESE | | [K842723](https://fda.innolitics.com/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KIP/K842723.md) | SALINE, 1.3% W/O PRESERVATIVE | E K Ind., Inc. | Aug 3, 1984 | SESE | | [K820928](https://fda.innolitics.com/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KIP/K820928.md) | EBS POWDER | Dutchland Laboratories, Inc. | Apr 21, 1982 | SESE | | [K820927](https://fda.innolitics.com/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KIP/K820927.md) | HBS POWDER | Dutchland Laboratories, Inc. | Apr 21, 1982 | SESE | | [K820923](https://fda.innolitics.com/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KIP/K820923.md) | DULBECCO'S PBS POWDER | Dutchland Laboratories, Inc. | Apr 21, 1982 | SESE | | [K810779](https://fda.innolitics.com/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KIP/K810779.md) | EARLE'S BALANCED SALTS SOULTION | Dutchland Laboratories, Inc. | May 13, 1981 | SESE | | [K810777](https://fda.innolitics.com/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KIP/K810777.md) | HANKS' BALANCED SALTS SOLUTION (MODIF.) | Dutchland Laboratories, Inc. | May 8, 1981 | SESE | | [K810766](https://fda.innolitics.com/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KIP/K810766.md) | HANKS' BALANCED SALT SOLUTION W/O CA-MG | Dutchland Laboratories, Inc. | May 8, 1981 | SESE | | [K781391](https://fda.innolitics.com/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KIP/K781391.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KIP](https://fda.innolitics.com/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KIP) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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