Apolowako HBA1C, Glucose and Analyzer, Models 993-24601, 991-24401 and 993-25201
FDA 510(k) K080123 · Wako Chemicals USA, Inc.
510(k) numberK080123
Submission
- Device name
- Apolowako HBA1C, Glucose and Analyzer, Models 993-24601, 991-24401 and 993-25201
- Applicant
- Wako Chemicals USA, Inc.
Richmond, VA, US - Received
- January 17, 2008
- Decision date
- July 17, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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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| K123018 | Ace Alera Clinical Chemistry System, Ace Glucose Reagent, Ace Ion Selective Electrode…CFR · Traditional | Alfa Wassermann Diagnostic Technologies, Inc. | 04/23/2013SE |
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| K042550 | Multi-Lipid CalibratorJIX · Traditional | 11/08/2004SE |
| K042549 | Multi Chem Cal BJIX · Traditional | 11/08/2004SE |
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Questions and answers
When was Apolowako HBA1C, Glucose and Analyzer, Models 993-24601, 991-24401 and 993-25201 cleared by the FDA?
Apolowako HBA1C, Glucose and Analyzer, Models 993-24601, 991-24401 and 993-25201 (K080123) received a 510(k) decision of Substantially Equivalent on July 17, 2008, 182 days after the submission was received.
What is the product code of K080123?
The FDA product code is CFR – Hexokinase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.