Glyco-Sep/Alc Test Kit for Separat of Hemoglobin
FDA 510(k) K852986 · Clinical Technology Corp.
510(k) numberK852986
Submission
- Device name
- Glyco-Sep/Alc Test Kit for Separat of Hemoglobin
- Applicant
- Clinical Technology Corp.
Rocky Point, NY, US - Received
- July 15, 1985
- Decision date
- August 19, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LCP – Assay, Glycosylated Hemoglobin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7470
- Specialty
- Hematology
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| K231465 | Q-Pad Test SystemLCP · Traditional | Qurasense | 12/06/2023SE |
| K214117 | Afinion HbA1c, Afinion 2 and Alere Afinion AS100 AnalyzerLCP · Dual Track | Abbott Diagnostics Technologies AS | 09/27/2023SE |
| K192987 | Aina HbA1c Monitoring System 2LCP · Traditional | Jana Care, Inc. | 03/26/2020SE |
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| K183230 | OneDraw A1C Test SystemLCP · Traditional | Drawbridge Health, Inc. | 08/15/2019SE |
| K181915 | PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test KitLCP · Traditional | Ixensor Co, Ltd. | 04/12/2019SE |
| K180509 | Quo-Test A1c SystemLCP · Dual Track | Ekf-Diagnostic GmbH | 02/16/2019SE |
| K173127 | skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent…LCP · Traditional | Skyla Corporation H.S.P.B | 09/25/2018SE |
| K170623 | ACE Hemoglobin A1c (HbA1c) ReagentLCP · Traditional | Alfa Wassermann Diagnostic Technologies, LLC | 02/27/2018SE |
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| K880166 | Bovie Ultrasonic Surgical Aspirator, Model ME2000LFL · Traditional | 02/18/1988SE |
| K872705 | Bovie 400-CT Electrosurgical Generator (Unit)GEI · Traditional | 09/01/1987SE |
| K855138 | Bovie Ultrasonic Surgical SystemLBK · Traditional | 11/10/1986SE |
| K854231 | Electrosurgical Cutting & Coagulation Device/AccesGEI · Traditional | 05/02/1986SE |
| K853507 | Steri-Grip · Traditional | 09/05/1985SE |
| K844565 | Bovie X-10 Electrosurgical Generator(Unit)GEI · Traditional | 02/21/1985SE |
| K841272 | Sickle-Stat Hemoglobin S Screen KitGHM · Traditional | 04/13/1984SE |
| K823077 | Urinary Bladder Temp. Sensor #81-003FLL · Traditional | 03/09/1983SE |
Questions and answers
When was Glyco-Sep/Alc Test Kit for Separat of Hemoglobin cleared by the FDA?
Glyco-Sep/Alc Test Kit for Separat of Hemoglobin (K852986) received a 510(k) decision of Substantially Equivalent on August 19, 1985, 35 days after the submission was received.
What is the product code of K852986?
The FDA product code is LCP – Assay, Glycosylated Hemoglobin, a Class II (moderate risk) device regulated under 21 CFR 864.7470.