Browse hierarchy: [Hematology (HE)](/submissions/HE) → [Subpart H — Hematology Kits and Packages](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages) → [21 CFR 864.7875](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/864.7875) → GJA — Test, Thrombin Time # GJA · Test, Thrombin Time _Hematology · 21 CFR 864.7875 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GJA ## Overview - **Product Code:** GJA - **Device Name:** Test, Thrombin Time - **Regulation:** [21 CFR 864.7875](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/864.7875) - **Device Class:** 2 - **Review Panel:** [Hematology](/submissions/HE) - **3rd-party reviewable:** yes ## Identification A thrombin time test is a device used to measure fibrinogen concentration and detect fibrin or fibrinogen split products for the evaluation of bleeding disorders. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 20) | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K050817](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GJA/K050817.md) | T-TEK | R2 Diagnostics, Inc. | Dec 12, 2005 | SESE | | [K982209](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GJA/K982209.md) | ACCUCLOT THROMBIN TIME REAGENT MODEL A8713/A4589 | Sigma Diagnostics, Inc. | Oct 15, 1998 | SESE | | [K970645](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GJA/K970645.md) | BC THROMBIN REAGENT | Behring Diagnostics, Inc. | May 19, 1997 | SESE | | [K925493](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GJA/K925493.md) | BIOMERIEUX HEMOLAB THROMBICALCI-TEST | Biomerieux Vitek, Inc. | Apr 21, 1994 | SESE | | [K930157](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GJA/K930157.md) | TEST THROMBIN | Behring Diagnostics, Inc. | May 14, 1993 | SESE | | [K923220](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GJA/K923220.md) | THROMBIN CLOT TIME TEST PROCEDURE | Medical Laboratory Automation Systems, Inc. | Sep 29, 1992 | SESE | | [K920147](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GJA/K920147.md) | THROMBIN CLOTTING TIME REAGENT | Helena Laboratories | May 1, 1992 | SESE | | [K900126](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GJA/K900126.md) | TT AND HNTT BY HEMOCHRON | International Technidyne Corp. | Feb 5, 1990 | SESE | | [K894467](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GJA/K894467.md) | THROMBIN TIME REAGENT | Sigma Chemical Co. | Sep 5, 1989 | SESE | | [K884385](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GJA/K884385.md) | FIBRI-PREST/THROMBIN-PREST CONTROLS | American Bioproducts Co. | Dec 28, 1988 | SESE | | [K884384](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GJA/K884384.md) | THROMBIN-PREST REAGENT KIT | American Bioproducts Co. | Dec 28, 1988 | SESE | | [K862301](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GJA/K862301.md) | IL SYSTEM 810, ACL AND THE REAGENT SETS | Instrumentation Laboratory CO | Sep 3, 1986 | SESE | | [K845000](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GJA/K845000.md) | THROMBINEX BOVINE THROMBIN | Bio/Data Corp. | Mar 26, 1985 | SESE | | [K841956](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GJA/K841956.md) | BOVINE THROMBIN, HUMAN THROMBIN | Haemachem, Inc. | Jul 19, 1984 | SESE | | [K834301](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GJA/K834301.md) | THROMBOLYTIC ACTIVITY TEST | Bio/Data Corp. | Feb 4, 1984 | SESE | | [K822466](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GJA/K822466.md) | THROMBIN TIME TEST | American Dade | Sep 14, 1982 | SESE | | [K811109](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GJA/K811109.md) | THROMBIN CLOTTING TIME | Bio/Data Corp. | Jul 16, 1981 | SESE | | [K802117](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GJA/K802117.md) | FIBRI QUIK | General Diagnostics | Sep 26, 1980 | SESE | | [K800926](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GJA/K800926.md) | THROMBOQUIK THROMBIN REAGENT PROD. #3551 | General Diagnostics | May 8, 1980 | SESE | | [K781781](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GJA/K781781.md) | HEPARSORB | General Diagnostics | Jan 10, 1979 | SESE | ## Top Applicants - Bio/Data Corp. — 3 clearances - General Diagnostics — 3 clearances - American Bioproducts Co. — 2 clearances - Behring Diagnostics, Inc. — 2 clearances - American Dade — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GJA](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GJA) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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