Fast Flow #60310
FDA 510(k) K791365 · Hi Chem, Inc.
510(k) numberK791365
Submission
- Device name
- Fast Flow #60310
- Applicant
- Hi Chem, Inc.
Mchenry, IL, US - Received
- July 25, 1979
- Decision date
- September 27, 1979
- 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
Other 510(k)s with product code LCP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K221326 | Nova Allegro HbA1c Assay, Nova Allegro AnalyzerLCP · Dual Track | Nova Biomedical Corporation | 11/22/2024SE |
| 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 |
More from Alfa Wassermann Diagnostic Technologies, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K960084 | Hichem Glucose/Hk Reagent KitCFR · Traditional | 04/04/1996SE |
| K951818 | Hichem Alt Reagent KitCKA · Traditional | 05/15/1995SE |
| K943684 | Hichem Enzyme Verifier KitJJT · Traditional | 10/04/1994SE |
| K941764 | Hichem Calcium Reagent for the Synchron CX3 Prod. No. 88808CJY · Traditional | 05/13/1994SE |
| K902673 | Hi Chem Total Protein/Albumin Serum Range Lin STNDJJY · Traditional | 07/17/1990SE |
| K863617 | Ion 2/4 Flow Cell Cleaner (Product #88656)JGS · Traditional | 10/24/1986SE |
| K862027 | LDP Reagent Cartridge (No. 88216)CFJ · Traditional | 06/13/1986SE |
| K861893 | GGT Reagent Cartridge (Product No. 88204)JXL · Traditional | 06/05/1986SE |
| K861879 | CK Reagent Cartridge (Product No. 88213)CGS · Traditional | 05/29/1986SE |
| K861419 | Hi Chem Diagnostics LDL Reagent CartridgeCFJ · Traditional | 04/28/1986SE |
Questions and answers
When was Fast Flow #60310 cleared by the FDA?
Fast Flow #60310 (K791365) received a 510(k) decision of Substantially Equivalent on September 27, 1979, 64 days after the submission was received.
What is the product code of K791365?
The FDA product code is LCP – Assay, Glycosylated Hemoglobin, a Class II (moderate risk) device regulated under 21 CFR 864.7470.