Wako Autokit CH50
FDA 510(k) K954145 · Wako Chemicals USA, Inc.
510(k) numberK954145
Submission
- Device name
- Wako Autokit CH50
- Applicant
- Wako Chemicals USA, Inc.
Richmond, VA, US - Received
- September 5, 1995
- Decision date
- December 18, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DAE – Complement C9, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5240
- Specialty
- Immunology
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| K992488 | Total Haemolytic Complement Rid KitDAE · Traditional | The Binding Site, Ltd. | 09/17/1999SE |
| K974111 | Quidel CH50 Eq EiaDAE · Traditional | Quidel Corp. | 07/29/1998SE |
| K951639 | Complement Activation Eia Test System (Cae)DAE · Traditional | Incstar Corp. | 10/13/1995SE |
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| 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 |
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Questions and answers
When was Wako Autokit CH50 cleared by the FDA?
Wako Autokit CH50 (K954145) received a 510(k) decision of Substantially Equivalent on December 18, 1995, 104 days after the submission was received.
What is the product code of K954145?
The FDA product code is DAE – Complement C9, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5240.