Control for Ph,Blood Gases,Eletrolytes,Glucose
FDA 510(k) K911755 · Bionostics, Inc.
510(k) numberK911755
Submission
- Device name
- Control for Ph,Blood Gases,Eletrolytes,Glucose
- Applicant
- Bionostics, Inc.
Acton, MA, US - Received
- April 18, 1991
- Decision date
- May 22, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JJY – Multi-Analyte Controls, All Kinds (Assayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JJY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K162530 | Multichem IA PlusJJY · Abbreviated | Techno-Path Manufacturing | 03/31/2017SE |
| K163629 | Audit MicroControls Linearity FD Tumor Markers IIJJY · Traditional | Aalto Scientific, Ltd. | 03/10/2017SE |
| K163015 | Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2…JJY · Traditional | Bio-Rad Laboratories | 01/10/2017SE |
| K153712 | VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification…JJY · Traditional | Radiometer America, Inc. | 01/28/2016SE |
| K150300 | Liquichek Cardiac Markers Plus Control LTJJY · Traditional | Bio-Rad Laboratories | 12/11/2015SE |
| K142964 | VALIDATE Anemia Calibration Verification/ Linearity Test KitJJY · Traditional | Maine Standards Company, LLC | 04/30/2015SE |
| K143379 | Liquichek Maternal Serum II ControlJJY · Traditional | Bio-Rad Laboratories | 03/13/2015SE |
| K143573 | Audit MicroControls Linearity FD Tumor Markers IIJJY · Traditional | Aalto Scientific, Ltd. | 01/16/2015SE |
| K140971 | Liquid Assayed Chemistry Control Premium Plus Level 1,2 and Level 3.JJY · Traditional | Randox Laboratories Limited | 12/08/2014SE |
| K142978 | Audit MicroControls Linearity LQ Special DiabetesJJY · Traditional | Aalto Scientific, Ltd. | 11/20/2014SE |
More from Aalto Scientific, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K131136 | Glucose Meter-Check Solution for TaidocJJX · Traditional | 05/31/2013SE |
| K123851 | Glucose Meter-Check Solution for Roche Accu-ChekJJX · Traditional | 02/14/2013SE |
| K123966 | Glucose Meter-Check Solution for BayerJJX · Traditional | 01/25/2013SE |
| K113764 | Glucose Meter-Check Solution for InfopiaJJX · Traditional | 01/30/2012SE |
| K112352 | Glucose Meter-Check Control for Nipro TrueresultJJX · Traditional | 12/23/2011SE |
| K112356 | Glucose Meter-Check Control Solution for Agamatrix WavesenseJJX · Traditional | 09/19/2011SE |
| K103553 | Lifescan Onetouch Select / Ultra / Vita Glucose Control SolutionJJX · Traditional | 02/10/2011SE |
| K101831 | Enterix Insurefit Fob Controls, Model 16800OSL · Traditional | 10/01/2010SE |
| K091914 | Omnis Health Embrace Glucose Control SolutionJJX · Traditional | 11/06/2009SE |
| K081478 | RNA Medical Glucose and B-Ketone Calibration Verification ControlsJJX · Traditional | 10/06/2008SE |
Questions and answers
When was Control for Ph,Blood Gases,Eletrolytes,Glucose cleared by the FDA?
Control for Ph,Blood Gases,Eletrolytes,Glucose (K911755) received a 510(k) decision of Substantially Equivalent on May 22, 1991, 34 days after the submission was received.
What is the product code of K911755?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.