GAL-1A Plus Blood Glucose Monitoring System
FDA 510(k) K213887 · Apex BioTechnology Corp.
510(k) numberK213887
Submission
- Device name
- GAL-1A Plus Blood Glucose Monitoring System
- Applicant
- Apex BioTechnology Corp.
Hsinchu, CN - Received
- December 13, 2021
- Decision date
- March 29, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NBW – System, Test, Blood Glucose, Over The Counter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1345
- Specialty
- Clinical Chemistry
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|---|---|---|---|
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| K250085 | On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood…NBW · Traditional | ACON Laboratories, Inc. | 10/10/2025SE |
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| K240637 | RIGHTEST Blood Glucose Monitoring System Max TelNBW · Traditional | Bionime Corporation | 11/04/2024SE |
| K240640 | Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring SystemNBW · Traditional | Sejoy Biomedical Co., Ltd. | 10/08/2024SE |
| K241787 | CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose…NBW · Traditional | Ascensia Diabetes Care U.S., Inc. | 08/27/2024SE |
| K222126 | VivaChek Fad Blood Glucose Monitoring System, VivaChek Fad Smart Blood Glucose…NBW · Traditional | Vivachek Biotech (Hangzhou) Co., Ltd. | 08/16/2024SE |
| K241304 | WaveSense Jazz Blood Glucose Monitoring SystemNBW · Special | Agamatrix | 06/06/2024SE |
| K231679 | CONTOUR® PLUS BLUE Blood Glucose Monitoring SystemNBW · Traditional | Ascensia Diabetes Care | 02/23/2024SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K242209 | UASure II Blood Uric Acid Monitoring SystemPTC · Traditional | 04/04/2025SE |
| K222234 | GlucoSure ADVANCE Link Blood Glucose Monitoring SystemNBW · Special | 12/21/2022SE |
| K220421 | BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring SystemNBW · Special | 11/04/2022SE |
| K212140 | GlucoSure Link Blood Glucose Monitoring SystemNBW · Traditional | 08/25/2022SE |
| K202534 | MTM301 Blood Glucose and Ketone Monitoring SystemNBW · Traditional | 04/06/2022SE |
| K201880 | MultiSure GK Link Blood Glucose and Ketone Monitoring SystemNBW · Traditional | 10/15/2021SE |
| K202885 | GlucoSure HT Plus Blood Glucose Monitoring SystemNBW · Special | 09/15/2021SE |
| K182593 | KET-1 Blood Ketone Monitoring SystemJIN · Traditional | 12/18/2018SE |
| K182992 | BGM014 Blood Glucose Monitoring SystemNBW · Special | 11/28/2018SE |
| K170267 | BGM009 Plus Blood Glucose Monitoring SystemNBW · Special | 03/09/2017SE |
Questions and answers
When was GAL-1A Plus Blood Glucose Monitoring System cleared by the FDA?
GAL-1A Plus Blood Glucose Monitoring System (K213887) received a 510(k) decision of Substantially Equivalent on March 29, 2022, 106 days after the submission was received.
What is the product code of K213887?
The FDA product code is NBW – System, Test, Blood Glucose, Over The Counter, a Class II (moderate risk) device regulated under 21 CFR 862.1345.