Hemagen CRP 150 Kit (Eia Method)
FDA 510(k) K960324 · Hemagen Diagnostics, Inc.
510(k) numberK960324
Submission
- Device name
- Hemagen CRP 150 Kit (Eia Method)
- Applicant
- Hemagen Diagnostics, Inc.
Waltham, MA, US - Received
- January 23, 1996
- Decision date
- March 12, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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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| K141689 | FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity C-Reactive…DCK · Traditional | Qualigen, Inc. | 01/07/2015SE |
| K121558 | Diazyme Hscrp Poc Test KitDCK · Traditional | Diazyme Laboratories | 09/21/2012SE |
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Questions and answers
When was Hemagen CRP 150 Kit (Eia Method) cleared by the FDA?
Hemagen CRP 150 Kit (Eia Method) (K960324) received a 510(k) decision of Substantially Equivalent on March 12, 1996, 49 days after the submission was received.
What is the product code of K960324?
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.