Browse hierarchy: [Hematology (HE)](/submissions/HE) → [Subpart I — Hematology Reagents](/submissions/HE/subpart-i%E2%80%94hematology-reagents) → [21 CFR 864.8200](/submissions/HE/subpart-i%E2%80%94hematology-reagents/864.8200) → GIF — Diluent, Blood Cell # GIF · Diluent, Blood Cell _Hematology · 21 CFR 864.8200 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/GIF ## Overview - **Product Code:** GIF - **Device Name:** Diluent, Blood Cell - **Regulation:** [21 CFR 864.8200](/submissions/HE/subpart-i%E2%80%94hematology-reagents/864.8200) - **Device Class:** 1 - **Review Panel:** [Hematology](/submissions/HE) ## Identification A blood cell diluent is a device used to dilute blood for further testing, such as blood cell counting. ## Classification Rationale Class I (general controls). This device is 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 38) Showing 20 most recent of 38 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K883990](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/GIF/K883990.md) | KVM ISOTONIC DILUENT | Kvm Technologies, Inc. | Oct 12, 1988 | SESE | | [K883989](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/GIF/K883989.md) | KVM ISOTONIC FLUSH SOLUTION | Kvm Technologies, Inc. | Oct 12, 1988 | SESE | | [K882490](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/GIF/K882490.md) | HYCEL QUICK-LYSING HEMOGLOBIN REAGENT | R&D Systems, Inc. | Jul 25, 1988 | SESE | | [K882267](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/GIF/K882267.md) | SYSMEX QUICKLYSER-II (QLS-200A) | Toa Medical Electronics USA, Inc. | Jul 12, 1988 | SESE | | [K881130](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/GIF/K881130.md) | CELL-DYN ISOTONIC DILUENT | Abbott Diagnostics | Mar 31, 1988 | SESE | | [K873347](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/GIF/K873347.md) | CELL-DYN DIFF. SCREEN ISOTONIC DILUENT | Abbott Diagnostics | Sep 9, 1987 | SESE | | [K851843](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/GIF/K851843.md) | OSMOCEL 3 | Hematology Marketing Assoc. | Jul 30, 1985 | SESE | | [K851320](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/GIF/K851320.md) | SDI PREPAX DILUKIT M. | Scientific Distributors, Inc. | Jul 5, 1985 | SESE | | [K851280](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/GIF/K851280.md) | DASS PACK | Dass, Inc. | Jul 5, 1985 | SESE | | [K850239](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/GIF/K850239.md) | SYSMEX HEMATOLOGICAL WHOLE BLOOD DILUTING REAGENT- | Toa Medical Electronics USA, Inc. | Apr 1, 1985 | SESE | | [K850095](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/GIF/K850095.md) | LASER-DIL | Hematology Marketing Assoc. | Mar 29, 1985 | SESE | | [K844782](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/GIF/K844782.md) | NSI ELT-D DILUTING FLUID 4000ML | Nobel Scientific Industries, Inc. | Mar 5, 1985 | SESE | | [K842929](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/GIF/K842929.md) | HAYEM DILUTING FLUID | E K Ind., Inc. | Sep 7, 1984 | SESE | | [K842068](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/GIF/K842068.md) | IDI ISOTONIC DILUENT | Interscience Diagnostics, Inc. | Jul 2, 1984 | SESE | | [K841799](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/GIF/K841799.md) | CYANOMETHEMOGLOBIN REAGENT | Reagent Laboratory, Inc. | May 31, 1984 | SESE | | [K840477](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/GIF/K840477.md) | UNITIZED HEMATOLOGY SET 65132/93 | Emd Chemicals, Inc. | Mar 5, 1984 | SESE | | [K840041](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/GIF/K840041.md) | SDI PREPAX DILUKIT HW | Scientific Distributors, Inc. | Mar 5, 1984 | SESE | | [K833972](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/GIF/K833972.md) | QUICK-COUNT HEMATOLOGY REAGENT KIT | Seragen Diagnostics, Inc. | Feb 17, 1984 | SESE | | [K840043](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/GIF/K840043.md) | SDI PREPAX DILUKIT CT | Scientific Distributors, Inc. | Feb 10, 1984 | SESE | | [K840038](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/GIF/K840038.md) | PREPAX DILUKIT PLUS | Scientific Distributors, Inc. | Feb 10, 1984 | SESE | ## Top Applicants - Scientific Distributors, Inc. — 4 clearances - Hematology Marketing Assoc. — 3 clearances - Abbott Diagnostics — 2 clearances - Harleco — 2 clearances - Kvm Technologies, Inc. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/GIF](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/GIF) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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