Glycohemoglobin
FDA 510(k) K931183 · Teco Diagnostics
510(k) numberK931183
Submission
- Device name
- Glycohemoglobin
- Applicant
- Teco Diagnostics
Placentia, CA, US - Received
- March 9, 1993
- Decision date
- November 5, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| K192369 | PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test KitLCP · Traditional | Ixensor Co, Ltd. | 10/29/2019SE |
| 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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| K160372 | Uritek TC-201 Urine Chemistry Test SystemJIL · Traditional | 07/22/2016SE |
| K152835 | Uritek TC-201 Urine Chemistry Test SystemJFY · Traditional | 03/07/2016SE |
| K141289 | Tc-Thunderbolt Automated Urine Analyzer System and Tc-Thunderbolt URS-10 StripsJIL · Traditional | 07/24/2015SE |
| K131600 | URS-2GP (Glucose Protein) Urine StripsJIL · Traditional | 05/29/2014SE |
| K111206 | Teco Diagnostics Saliva Alcohol TestDIC · Traditional | 10/04/2011SE |
| K100024 | Teco Diagnostics Uti Detection StripsJMT · Traditional | 02/17/2011SE |
| K101673 | Uritek TC-101 Urine Analyzer, Urine Reagent Strips 10, Models TC-101, URS-10JIL · Traditional | 02/04/2011SE |
Questions and answers
When was Glycohemoglobin cleared by the FDA?
Glycohemoglobin (K931183) received a 510(k) decision of Substantially Equivalent on November 5, 1993, 241 days after the submission was received.
What is the product code of K931183?
The FDA product code is LCP – Assay, Glycosylated Hemoglobin, a Class II (moderate risk) device regulated under 21 CFR 864.7470.