Goodlife AC-300 Blood Glucose Monitoring System, Goodlife AC-301 Blood Glucose Monitoring System, Goodlife AC-302 Blood Glucose Monitoring System, Goodlife AC 303 Blood Glucose Monitoring System, Goodlife AC-304 Blood Glucose Monitoring System Goodlife AC-305 Blood Glucose Monitoring System, Goodlife AC-300 Professional Blood Glucose Monitoring System, Goodlife AC-301 Professional Blood Glucose Mo
FDA 510(k) K140150 · Hmd Biomedical, Inc.
510(k) numberK140150
Submission
- Device name
- Goodlife AC-300 Blood Glucose Monitoring System, Goodlife AC-301 Blood Glucose Monitoring System, Goodlife AC-302 Blood Glucose Monitoring System, Goodlife AC 303 Blood Glucose Monitoring System, Goodlife AC-304 Blood Glucose Monitoring System Goodlife AC-305 Blood Glucose Monitoring System, Goodlife AC-300 Professional Blood Glucose Monitoring System, Goodlife AC-301 Professional Blood Glucose Mo
- Applicant
- Hmd Biomedical, Inc.
Hsinchu County, TW - Received
- January 22, 2014
- Decision date
- May 14, 2015
- 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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| 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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| K182428 | GlucoLeader Enhance Blood Glucose Monitoring SystemNBW · Traditional | 05/08/2019SE |
| K131173 | FIA Blood Glucose Monitoring System (G2)NBW · Traditional | 09/18/2014SE |
| K121433 | Goodlife CS-200 (Single Patient Use), CS-200 Professional (Multiple Patient Use) Blood…LFR · Traditional | 02/14/2013SE |
| K113314 | Precichek NS-101 Poct Professional Blood Glucose Monitoring SystemLFR · Traditional | 11/09/2012SE |
| K120064 | Test, Blood Glucose SystemNBW · Traditional | 09/05/2012SE |
| K113307 | GL Goodlife Series Blood Glucose Monitoring SysmtemLFR · Traditional | 07/27/2012SE |
| K072369 | Evolution Blood Glucose Monitoring SystemNBW · Traditional | 03/21/2008SE |
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| K023279 | Glucoleader ValueNBW · Traditional | 08/04/2003SE |
Questions and answers
When was Goodlife AC-300 Blood Glucose Monitoring System, Goodlife AC-301 Blood Glucose Monitoring System, Goodlife AC-302 Blood Glucose Monitoring System, Goodlife AC 303 Blood Glucose Monitoring System, Goodlife AC-304 Blood Glucose Monitoring System Goodlife AC-305 Blood Glucose Monitoring System, Goodlife AC-300 Professional Blood Glucose Monitoring System, Goodlife AC-301 Professional Blood Glucose Mo cleared by the FDA?
Goodlife AC-300 Blood Glucose Monitoring System, Goodlife AC-301 Blood Glucose Monitoring System, Goodlife AC-302 Blood Glucose Monitoring System, Goodlife AC 303 Blood Glucose Monitoring System, Goodlife AC-304 Blood Glucose Monitoring System Goodlife AC-305 Blood Glucose Monitoring System, Goodlife AC-300 Professional Blood Glucose Monitoring System, Goodlife AC-301 Professional Blood Glucose Mo (K140150) received a 510(k) decision of Substantially Equivalent on May 14, 2015, 477 days after the submission was received.
What is the product code of K140150?
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.