Ultrachem E-Glu, #64976 & 65040
FDA 510(k) K821461 · Emd Chemicals, Inc.
510(k) numberK821461
Submission
- Device name
- Ultrachem E-Glu, #64976 & 65040
- 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
- CFR – Hexokinase, Glucose
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1345
- Specialty
- Clinical Chemistry
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| K220134 | cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT…CFR · Traditional | Roche Diagnostics | 09/16/2022SE |
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| K170316 | Alinity C Glucose Reagent Kit, Alinity C SystemCFR · Traditional | Abbott Laboratories | 10/19/2017SE |
| K153644 | ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech…CFR · Traditional | Elitechgroup | 09/07/2016SE |
| K151487 | Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose Hexokinase…CFR · Traditional | Diatron U.S., Inc. | 01/14/2016SE |
| K131189 | Unicel DXC Synchron Systems Glucose Reagent (Gluh)CFR · Traditional | Beckman Coulter, Inc. | 04/17/2014SE |
| K123018 | Ace Alera Clinical Chemistry System, Ace Glucose Reagent, Ace Ion Selective Electrode…CFR · Traditional | Alfa Wassermann Diagnostic Technologies, Inc. | 04/23/2013SE |
| K120681 | Advia Chemistry GLUH_3 ReagentsCFR · Traditional | Siemens Healthcare Diagnostics, Inc. | 05/15/2012SE |
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| K981926 | Ethyl Alcohol Clinical Standard SolutionsDLJ · Traditional | 07/22/1998SE |
| K973054 | Ethyl Alcohol Clinical Standard SolutionsDNN · Traditional | 10/01/1997SE |
| 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 |
| K950128 | Total Protein Test (Tpro) Item XXXXX/R1. R2CEK · Traditional | 05/15/1995SE |
| K945322 | Phosphorus Test (Phos) Item Number 65416CEO · Traditional | 12/07/1994SE |
| K945368 | Phosphorus Test (Phos)CEO · Traditional | 12/02/1994SE |
Questions and answers
When was Ultrachem E-Glu, #64976 & 65040 cleared by the FDA?
Ultrachem E-Glu, #64976 & 65040 (K821461) 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 K821461?
The FDA product code is CFR – Hexokinase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.