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 864.2800](/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/864.2800) → KIS — Sera, Animal And Human # KIS · Sera, Animal And Human _Hematology · 21 CFR 864.2800 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KIS ## Overview - **Product Code:** KIS - **Device Name:** Sera, Animal And Human - **Regulation:** [21 CFR 864.2800](/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/864.2800) - **Device Class:** 1 - **Review Panel:** [Hematology](/submissions/HE) ## Identification Animal and human sera are biological products, obtained from the blood of humans or other animals, that provide the necessary growth-promoting nutrients in a cell culture system. ## 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 (20 of 45) Showing 20 most recent of 45 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K881287](https://fda.innolitics.com/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KIS/K881287.md) | ANIMAL AND HUMAN SERA | Cell Culture Laboratories | Apr 5, 1988 | SESE | | [K880471](https://fda.innolitics.com/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KIS/K880471.md) | BOVINE CALF SERUM SUPPLEMENTED #A-2159 | Hyclone Laboratories, Inc. | Apr 4, 1988 | SESE | | [K880470](https://fda.innolitics.com/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KIS/K880470.md) | BOVINE CALF SERUM CATALOG #A-2119 | Hyclone Laboratories, Inc. | Apr 1, 1988 | SESE | | [K872847](https://fda.innolitics.com/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KIS/K872847.md) | SOLCOSERYL TISSUE CULTURE GROWTH SUPPLEMENT | Candace Lane Corp. | Aug 10, 1987 | SESE | | [K870580](https://fda.innolitics.com/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KIS/K870580.md) | MLC NORMAL SERUM | Rjo Biologicals, Inc. | Apr 8, 1987 | SESE | | [K870938](https://fda.innolitics.com/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KIS/K870938.md) | FETAL BOVINE SERUM | Hyclone Laboratories, Inc. | Mar 31, 1987 | SESE | | [K870469](https://fda.innolitics.com/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KIS/K870469.md) | DEFINED EQUINE SERUM #A-3311 | Hyclone Laboratories, Inc. | Mar 24, 1987 | SESE | | [K870468](https://fda.innolitics.com/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KIS/K870468.md) | ADULT BOVINE SERUM | Hyclone Laboratories, Inc. | Mar 24, 1987 | SESE | | [K870467](https://fda.innolitics.com/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KIS/K870467.md) | DEFINED CALF BOVINE SERUM SUPPLEMENTED #A-2151 | Hyclone Laboratories, Inc. | Mar 24, 1987 | SESE | | [K870466](https://fda.innolitics.com/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KIS/K870466.md) | DEFINED CALF BOVINE SERUM #A-2111 | Hyclone Laboratories, Inc. | Mar 24, 1987 | SESE | | [K870465](https://fda.innolitics.com/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KIS/K870465.md) | 6/40 FETAL BOVINE SERUM #A-1110 | Hyclone Laboratories, Inc. | Mar 24, 1987 | SESE | | [K870464](https://fda.innolitics.com/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KIS/K870464.md) | CHARACTERIZED FETAL BOVINE SERUM #A-1115 | Hyclone Laboratories, Inc. | Mar 24, 1987 | SESE | | [K870463](https://fda.innolitics.com/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KIS/K870463.md) | DEFINED FETAL BOVINE SERUM #A-1111 | Hyclone Laboratories, Inc. | Mar 24, 1987 | SESE | | [K861817](https://fda.innolitics.com/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KIS/K861817.md) | HORSE BLOOD CELLS IN ALSEVERS CITRATE/DEFIBRINATED | Hazleton Research Products, Inc. | May 20, 1986 | SESE | | [K861816](https://fda.innolitics.com/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KIS/K861816.md) | MOUSE BLOOD CELLS IN ALSEVERS OR CITRATE | Hazleton Research Products, Inc. | May 20, 1986 | SESE | | [K861815](https://fda.innolitics.com/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KIS/K861815.md) | BOVINE BLOOD CELLS IN ALSEVERS CITRATE/DEFIBRINATE | Hazleton Research Products, Inc. | May 20, 1986 | SESE | | [K861814](https://fda.innolitics.com/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KIS/K861814.md) | RHESUS MONKEY SERUM - STERILE FILTERED | Hazleton Research Products, Inc. | May 20, 1986 | SESE | | [K861813](https://fda.innolitics.com/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KIS/K861813.md) | HUMAN AB SERUM - STERILE FILTERED | Hazleton Research Products, Inc. | May 20, 1986 | SESE | | [K861812](https://fda.innolitics.com/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KIS/K861812.md) | HUMAN SERUM - STERILE FILTERED | Hazleton Research Products, Inc. | May 20, 1986 | SESE | | [K861811](https://fda.innolitics.com/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KIS/K861811.md) | MOUSE SERUM - STERILE FILTERED | Hazleton Research Products, Inc. | May 20, 1986 | SESE | ## Top Applicants - Hyclone Laboratories, Inc. — 10 clearances - Dutchland Laboratories, Inc. — 9 clearances - Hazleton Research Products, Inc. — 9 clearances - Biolabs, Inc. — 3 clearances - Flow Laboratories, Inc. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KIS](https://fda.innolitics.com/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KIS) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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