Safe At-Home Test Kit for Monitoring Hemoglobin Alc
FDA 510(k) K991850 · Biosafe Laboratories, Inc.
510(k) numberK991850
Submission
- Device name
- Safe At-Home Test Kit for Monitoring Hemoglobin Alc
- Applicant
- Biosafe Laboratories, Inc.
Lincolnshire, IL, US - Received
- June 1, 1999
- Decision date
- November 26, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
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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 |
More from Alfa Wassermann Diagnostic Technologies, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K042379 | Anemiapro Self-ScreenerKHG · Traditional | 12/15/2004SE |
| K012221 | Safe at Home Cholesterol Profile Blood Collection and Transport SystemJKA · Traditional | 04/03/2002SE |
| K011970 | Biosafe Cholesterol Profile Blood Collection and Transport SystemCHH · Traditional | 09/26/2001SE |
| K011525 | Safe at Home TSH (Thyroid Stimulating Hormone Blood Collection and Transport System)JLW · Traditional | 07/16/2001SE |
| K003752 | Biosafe Capillary Blood Transport System for Testing Thyroid Stimulating Hormone (TSH)JLW · Traditional | 03/23/2001SE |
Questions and answers
When was Safe At-Home Test Kit for Monitoring Hemoglobin Alc cleared by the FDA?
Safe At-Home Test Kit for Monitoring Hemoglobin Alc (K991850) received a 510(k) decision of Substantially Equivalent on November 26, 1999, 178 days after the submission was received.
What is the product code of K991850?
The FDA product code is LCP – Assay, Glycosylated Hemoglobin, a Class II (moderate risk) device regulated under 21 CFR 864.7470.