Wako L-Type Creatinine-M Test, and Wako Creatinine Calibrator
FDA 510(k) K061775 · Wako Chemicals USA, Inc.
510(k) numberK061775
Submission
- Device name
- Wako L-Type Creatinine-M Test, and Wako Creatinine Calibrator
- Applicant
- Wako Chemicals USA, Inc.
Richmond, VA, US - Received
- June 23, 2006
- Decision date
- February 23, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JFY – Enzymatic Method, Creatinine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1225
- Specialty
- Clinical Chemistry
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| K161527 | Teco Creatinine Enzymatic Reagent KitJFY · Traditional | Teco Diagnostics, Inc. | 07/21/2017SE |
| K152835 | Uritek TC-201 Urine Chemistry Test SystemJFY · Traditional | Teco Diagnostics, Inc. | 03/07/2016SE |
| K142391 | Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips (…JFY · Traditional | ACON Laboratories, Inc. | 12/22/2014SE |
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| K080123 | Apolowako HBA1C, Glucose and Analyzer, Models 993-24601, 991-24401 and 993-25201CFR · Traditional | 07/17/2008SE |
| K062368 | Wako Lba DCP Test System, Model 993-05301; DCP Control Set, Model 995-0551; DCP…OAU · Traditional | 01/31/2007SE |
| K053132 | Wako Direct Bilirubin V, Models 996-23591, 412-22901, 992-23691, 998-23791JFM · Traditional | 12/30/2005SE |
| K053131 | Wako Total Bilirubin V, Models 410-22701, 998-23291, 416-22801, 990-23191JFM · Traditional | 12/30/2005SE |
| K042551 | Multi-Chem Calibrator aJIX · Traditional | 11/16/2004SE |
| K042550 | Multi-Lipid CalibratorJIX · Traditional | 11/08/2004SE |
| K042549 | Multi Chem Cal BJIX · Traditional | 11/08/2004SE |
| K040918 | Wako Lipid Control, Level 1 and Level 2JJX · Traditional | 05/17/2004SE |
Questions and answers
When was Wako L-Type Creatinine-M Test, and Wako Creatinine Calibrator cleared by the FDA?
Wako L-Type Creatinine-M Test, and Wako Creatinine Calibrator (K061775) received a 510(k) decision of Substantially Equivalent on February 23, 2007, 245 days after the submission was received.
What is the product code of K061775?
The FDA product code is JFY – Enzymatic Method, Creatinine, a Class II (moderate risk) device regulated under 21 CFR 862.1225.