Browse hierarchy: [Hematology (HE)](/submissions/HE) → [Subpart H — Hematology Kits and Packages](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages) → [21 CFR 864.7290](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/864.7290) → GJT — Plasma, Coagulation Factor Deficient # GJT · Plasma, Coagulation Factor Deficient _Hematology · 21 CFR 864.7290 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GJT ## Overview - **Product Code:** GJT - **Device Name:** Plasma, Coagulation Factor Deficient - **Regulation:** [21 CFR 864.7290](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/864.7290) - **Device Class:** 2 - **Review Panel:** [Hematology](/submissions/HE) - **3rd-party reviewable:** yes ## Recent Cleared Devices (20 of 79) Showing 20 most recent of 79 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K222831](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GJT/K222831.md) | CRYOcheck Factor VIII Deficient Plasma with VWF | Precision Biologic, Inc. | Sep 13, 2023 | SESE | | [K180486](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GJT/K180486.md) | HemosIL Factor XII Deficient Plasma | Instrumentation Laboratory CO | Mar 22, 2018 | SESE | | [K102908](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GJT/K102908.md) | NOFACT IX | R2 Diagnostics, Inc. | Dec 19, 2011 | SESE | | [K102851](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GJT/K102851.md) | NOFACT VIII | R2 Diagnostics, Inc. | Dec 19, 2011 | SESE | | [K110237](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GJT/K110237.md) | HEMOSIL FACTOR VIII DEFICIENT PLASMA | Instrumentation Laboratory CO | Jul 8, 2011 | SESE | | [K050661](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GJT/K050661.md) | HEMOSIL FACTOR II DEFICIENT PLASMA | Instrumentation Laboratory CO | May 2, 2005 | SESE | | [K043459](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GJT/K043459.md) | HEMOSIL FACTOR XII DEFICIENT PLASMA | Instrumentation Laboratory CO | Feb 9, 2005 | SESE | | [K040362](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GJT/K040362.md) | DIAPHARMA FACTOR X KIT | Diapharma Group, Inc. | Jul 12, 2004 | SESE | | [K034007](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GJT/K034007.md) | HEMOSIL FACTOR VIII DEFICIENT PLASMA | Instrumentation Laboratory CO | Feb 13, 2004 | SESE | | [K031829](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GJT/K031829.md) | HEMOSIL FACTOR IX DEFICIENT PLASMA | Instrumentation Laboratory CO | Jul 31, 2003 | SESE | | [K031122](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GJT/K031122.md) | HEMOSIL FACTOR X DEFICIENT PLASMA | Instrumentation Laboratory CO | May 19, 2003 | SESE | | [K030287](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GJT/K030287.md) | HEMOSIL FACTOR XI DEFICIENT PLASMA | Instrumentation Laboratory CO | Mar 19, 2003 | SESE | | [K024082](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GJT/K024082.md) | HEMOSIL FACTOR VII DEFICIENT PLASMA | Instrumentation Laboratory CO | Feb 12, 2003 | SESE | | [K023839](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GJT/K023839.md) | HEMOSIL FACTOR V DEFICIENT PLASMA | Instrumentation Laboratory CO | Jan 14, 2003 | SESE | | [K990814](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GJT/K990814.md) | CRYO CHECK FACTOR 2 DEFICIENT PLASMA, MODELS FDPO2-10, FDP02-15 | Precision Biologic | Jun 7, 1999 | SESE | | [K990296](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GJT/K990296.md) | CRYOCHECK PREKALLIKREIN DEFICIENT PLALSMA, MODEL FDPK10/10 (10 X 1.0 ML), FDPK10/25 (25 X 1.0ML) | Precision Biologic | Mar 18, 1999 | SESE | | [K990046](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GJT/K990046.md) | PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR VIII DEFICIENT PLASMA | Pacific Hemostasis | Feb 17, 1999 | SESE | | [K981174](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GJT/K981174.md) | CRYO CHECK FACTOR XII DEFICIENT PLASMA MODEL FDP12-10 (1.0ML) AND FDP12-15 (1.5ML) | Precision Biologicals, Inc. | Jan 13, 1999 | SESE | | [K981173](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GJT/K981173.md) | CRYO CHECK FACTOR XI DEFICIENT PLASMA, MODEL FDP11-10 (1.OML) AND FDP11-15 (1.5ML) | Precision Biologicals, Inc. | Jan 13, 1999 | SESE | | [K981709](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GJT/K981709.md) | COAGULATION FACTOR V DEFICIENT PLASMA | Dade Behring, Inc. | Oct 13, 1998 | SESE | ## Top Applicants - Instrumentation Laboratory CO — 10 clearances - Medical Diagnostic Technologies, Inc. — 10 clearances - American Bioproducts Co. — 9 clearances - Sigma Chemical Co. — 8 clearances - Precision Biologicals, Inc. — 7 clearances --- **Source:** [https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GJT](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GJT) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com