Browse hierarchy: [Clinical Chemistry (CH)](/submissions/CH) → [Subpart B — Clinical Chemistry Test Systems](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems) → [21 CFR 862.1160](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1160) → JFL — Ph Rate Measurement, Carbon-Dioxide # JFL · Ph Rate Measurement, Carbon-Dioxide _Clinical Chemistry · 21 CFR 862.1160 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFL ## Overview - **Product Code:** JFL - **Device Name:** Ph Rate Measurement, Carbon-Dioxide - **Regulation:** [21 CFR 862.1160](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1160) - **Device Class:** 2 - **Review Panel:** [Clinical Chemistry](/submissions/CH) - **3rd-party reviewable:** yes ## Identification A bicarbonate/carbon dioxide test system is a device intended to measure bicarbonate/carbon dioxide in plasma, serum, and whole blood. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance. ## Classification Rationale Class II. ## Recent Cleared Devices (20 of 28) Showing 20 most recent of 28 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K191298](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFL/K191298.md) | i-STAT CHEM8+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | Feb 7, 2020 | SESE | | [K040975](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFL/K040975.md) | GENCHEM CO2 ACID REAGENT | Genchem, Inc. | Dec 27, 2004 | SESE | | [K014034](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFL/K014034.md) | MODIFICATION TO SYNCHRON LX CLINICAL CHEMISTRY SYSTEMS (LX20 AND LX20 PRO) | Beckman Coulter, Inc. | Dec 18, 2001 | SESE | | [K963541](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFL/K963541.md) | SIGMA DIAGNOSTICS CO2 ACID REAGENT | Sigma Diagnostics, Inc. | Oct 24, 1996 | SESE | | [K963538](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFL/K963538.md) | SIGMA DIAGNOSTICS CO2ALKALINE BUFFER | Sigma Diagnostics, Inc. | Oct 11, 1996 | SESE | | [K963540](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFL/K963540.md) | SIGMA DIAGNOSTICS ELECTROLYTE BUFFER | Sigma Diagnostics, Inc. | Sep 27, 1996 | SESE | | [K963005](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFL/K963005.md) | NOVA 16 ANALYZER (MODIFICATION POINT OF CARE USAGE) | Nova Biomedical Corp. | Aug 23, 1996 | SESE | | [K933696](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFL/K933696.md) | SIGMA ELECTROLYTE REFERENCE REAGENT | Sigma Chemical Co. | Jan 3, 1994 | SESE | | [K933691](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFL/K933691.md) | SIGMA CO2 ALKALINE BUFFER REAGENT | Sigma Chemical Co. | Dec 17, 1993 | SESE | | [K933692](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFL/K933692.md) | SIGMA CO2 ACID REAGENT | Sigma Chemical Co. | Dec 9, 1993 | SESE | | [K933695](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFL/K933695.md) | SIGMA ELECTROLYTE BUFFER | Sigma Chemical Co. | Oct 22, 1993 | SESE | | [K925553](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFL/K925553.md) | HI CHEM CO2 ALKALINE BUFFER REAGENT KIT,PROD#88813 | Hichem Diagnostics | Feb 12, 1993 | SESE | | [K925552](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFL/K925552.md) | HI CHEM CO2 ACID REAGENT KIT,PRODUCT NUMBER 88812 | Hichem Diagnostics | Feb 12, 1993 | SESE | | [K900185](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFL/K900185.md) | NIIC MODEL: DX901 ASPIRATION SYSTEM | Niic U.S.A., Inc. | May 24, 1990 | SESE | | [K897183](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFL/K897183.md) | SYNCHRON EL-ISE(TM) ELECTROLYTE SYSTEMS | Beckman Instruments, Inc. | Mar 30, 1990 | SESE | | [K900420](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFL/K900420.md) | BICARBONATE REAGENTS PRODUCT #7713 & #7714 | American Research Products Co. | Mar 1, 1990 | SESE | | [K873129](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFL/K873129.md) | CARBON DIOXIDE REAGENT KIT | A-Kem, Inc. | Oct 23, 1987 | SESE | | [K842656](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFL/K842656.md) | REPLACEMENT PARTS NOVA ELECTROLYTE ANAL | Shaban Mfg. Co. | Aug 12, 1984 | SESE | | [K822117](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFL/K822117.md) | FERMCOTEST CO2 REAGNET | Fermco Biochemics, Inc. | Sep 30, 1982 | SESE | | [K820388](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFL/K820388.md) | LIQUIZYME CO2REAGENT SET | American Research Products Co. | Mar 8, 1982 | SESE | ## Top Applicants - Sigma Chemical Co. — 4 clearances - Sigma Diagnostics, Inc. — 3 clearances - American Research Products Co. — 2 clearances - Hi Chem, Inc. — 2 clearances - Hichem Diagnostics — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFL](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFL) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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