On Call Pro Blood Glucose Monitoring System
FDA 510(k) K161867 · Acon Laboratories
510(k) numberK161867
Submission
- Device name
- On Call Pro Blood Glucose Monitoring System
- Applicant
- Acon Laboratories
San Diego, CA, US - Received
- July 7, 2016
- Decision date
- August 5, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement 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
Other 510(k)s with product code NBW
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|---|---|---|---|
| K260545 | CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose…NBW · Traditional | Ascensia Diabetes Care | 08/27/2026SE |
| K262116 | TRUE METRIX Self Monitoring Blood Glucose SystemNBW · Special | Trividia Health, Inc. | 07/23/2026SE |
| K250085 | On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood…NBW · Traditional | ACON Laboratories, Inc. | 10/10/2025SE |
| K243060 | TeleRPM Gen2 Blood Glucose Monitoring SystemNBW · Traditional | Guangdong Transtek Medical Electronics Co., Ltd. | 01/30/2025SE |
| 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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| K251749 | Flowflex Plus RSV + Flu A/B + COVID Home TestSCA · Traditional | 10/22/2025SE |
| K250085 | On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood…NBW · Traditional | 10/10/2025SE |
| K250377 | Flowflex Plus COVID-19 + Flu A/B Home TestSCA · Traditional | 05/10/2025SE |
| K232715 | Distinct® Digital Pregnancy TestLCX · Traditional | 05/31/2024SE |
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| K193318 | Distinct® Early Detection Pregnancy TestLCX · Traditional | 08/20/2020SE |
| K192175 | On Call Express II Blood Glucose Monitoring SystemNBW · Special | 10/17/2019SE |
Questions and answers
When was On Call Pro Blood Glucose Monitoring System cleared by the FDA?
On Call Pro Blood Glucose Monitoring System (K161867) received a 510(k) decision of Substantially Equivalent on August 5, 2016, 29 days after the submission was received.
What is the product code of K161867?
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.