Hemagen C-Reactive Protein Kit (Eia Method)
FDA 510(k) K944288 · Hemagen Diagnostics, Inc.
510(k) numberK944288
Submission
- Device name
- Hemagen C-Reactive Protein Kit (Eia Method)
- Applicant
- Hemagen Diagnostics, Inc.
Waltham, MA, US - Received
- September 2, 1994
- Decision date
- October 3, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DCK – C-Reactive Protein, Antigen, Antiserum, And Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5270
- Specialty
- Immunology
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| K022767 | Raichem Lipid CalibratorJIX · Special | 09/03/2002SE |
| K021194 | Raichem CRP High Sensitivity Test SystemDCK · Traditional | 07/29/2002SE |
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Questions and answers
When was Hemagen C-Reactive Protein Kit (Eia Method) cleared by the FDA?
Hemagen C-Reactive Protein Kit (Eia Method) (K944288) received a 510(k) decision of Substantially Equivalent on October 3, 1994, 31 days after the submission was received.
What is the product code of K944288?
The FDA product code is DCK – C-Reactive Protein, Antigen, Antiserum, And Control, a Class II (moderate risk) device regulated under 21 CFR 866.5270.