Ultrachem Gluc-Dh, #65048
FDA 510(k) K821469 · Emd Chemicals, Inc.
510(k) numberK821469
Submission
- Device name
- Ultrachem Gluc-Dh, #65048
- Applicant
- Emd Chemicals, Inc.
Mchenry, IL, US - Received
- May 18, 1982
- Decision date
- June 2, 1982
- 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
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| 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 |
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| K951494 | Amylase Test Item 97381/94 (R1, 97382/94 (R2-SR)CIJ · Traditional | 12/11/1995SE |
| K951750 | Glucose Test Item Number 97375/94LFR · Traditional | 09/06/1995SE |
| K950234 | Total Protein Test (Tpro) Item Number: XXXXX/R1. R2CEK · Traditional | 06/14/1995SE |
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| K945322 | Phosphorus Test (Phos) Item Number 65416CEO · Traditional | 12/07/1994SE |
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Questions and answers
When was Ultrachem Gluc-Dh, #65048 cleared by the FDA?
Ultrachem Gluc-Dh, #65048 (K821469) received a 510(k) decision of Substantially Equivalent on June 2, 1982, 15 days after the submission was received.
What is the product code of K821469?
The FDA product code is LFR – Glucose Dehydrogenase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.