Ultrachem Gluc-Dh, Item No. 65048
FDA 510(k) K811202 · Harleco
510(k) numberK811202
Submission
- Device name
- Ultrachem Gluc-Dh, Item No. 65048
- Applicant
- Harleco
Mchenry, IL, US - Received
- May 1, 1981
- Decision date
- May 27, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LFR – Glucose Dehydrogenase, Glucose
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1345
- Specialty
- Clinical Chemistry
Other 510(k)s with product code LFR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K152328 | FreeStyle InsuLinx Blood Glucose Monotioring SystemLFR · Special | Abott Laboratories | 09/17/2015SE |
| K142089 | Accu-Chek Aviva Expert SystemLFR · Traditional | Roche Diagnostics Corporation | 12/17/2014SE |
| K133537 | EGV1.1 Self Monitoring Blood Glucose System and EGV1.1 Pro Monitoring Blood Glucose SystemLFR · Special | Eps Bio Technology Corp. | 04/28/2014SE |
| K131727 | Cera-Chek 1070 Blood Glucose Monitoring SystemLFR · Traditional | Ceragem Medisys, Inc. | 02/28/2014SE |
| K131366 | Accu-Chek Aviva Expert Blood Glucose Monitoring SystemLFR · Traditional | Roche Diagnostics Operations, Inc. | 10/11/2013SE |
| K122688 | Nova Max Mini Blood Glucose and B-Ketone MonitorLFR · Traditional | Nova Biomedical Corporation | 04/04/2013SE |
| K121433 | Goodlife CS-200 (Single Patient Use), CS-200 Professional (Multiple Patient Use) Blood…LFR · Traditional | Hmd Biomedical, Inc. | 02/14/2013SE |
| K122435 | Nova One Blood Glucose MonitorLFR · Traditional | Nova Biomedical Corporation | 12/20/2012SE |
| K113314 | Precichek NS-101 Poct Professional Blood Glucose Monitoring SystemLFR · Traditional | Hmd Biomedical, Inc. | 11/09/2012SE |
| K121224 | Genesis Health Technologies Blood Glucose Monitoring SystemLFR · Special | Taidoc Technology Corporation | 09/19/2012SE |
More from Taidoc Technology Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K820233 | Ultrazyme Plus Gamma GT(65055-65056)JQB · Traditional | 02/12/1982SE |
| K813427 | Ultrachem Gluc-DhLFR · Traditional | 12/31/1981SE |
| K813044 | Ultrachem Alb, Item #64970CIX · Traditional | 11/10/1981SE |
| K813043 | Ultrachem Crea Item #64972CGX · Traditional | 11/10/1981SE |
| K813042 | Ultrachem Gluc-Dh Set, Item #65048LFR · Traditional | 11/10/1981SE |
| K813041 | Ultrazyme-Gt, Item #64959 & 65032JQB · Traditional | 11/10/1981SE |
| K813040 | Ultrachem Ca, Item #64975CJY · Traditional | 11/10/1981SE |
| K813039 | Ultrachem E-Chol, Item #65025CHH · Traditional | 11/10/1981SE |
| K813038 | Ultrachem TP, Item #64974CEK · Traditional | 11/10/1981SE |
| K812594 | Ultra Zyme Plus Amyl #64982 & 65031CIJ · Traditional | 10/02/1981SE |
Questions and answers
When was Ultrachem Gluc-Dh, Item No. 65048 cleared by the FDA?
Ultrachem Gluc-Dh, Item No. 65048 (K811202) received a 510(k) decision of Substantially Equivalent on May 27, 1981, 26 days after the submission was received.
What is the product code of K811202?
The FDA product code is LFR – Glucose Dehydrogenase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.