Test, C-Reative Protein, Latex Slide
FDA 510(k) K760035 · Gamma Biologicals, Inc.
510(k) numberK760035
Submission
- Device name
- Test, C-Reative Protein, Latex Slide
- Applicant
- Gamma Biologicals, Inc.
Mchenry, IL, US - Received
- June 14, 1976
- Decision date
- August 3, 1976
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| K820647 | Gamma Fetal Bleed Screening TestLIM · Traditional | 05/12/1982SE |
| K820072 | Fe-Cult PlusKHE · Traditional | 03/04/1982SE |
| K813342 | Gamma Chloroquine Diphosphate SolutionKSK · Traditional | 03/04/1982SE |
| K811752 | Fe-Cult PlusKHE · Traditional | 11/02/1981SE |
| K802534 | Gamma Pi Blood Group SubstanceKSX · Traditional | 11/12/1980SE |
| K802533 | Gamma Lewis Blood Group SubstanceKSX · Traditional | 11/12/1980SE |
| K800658 | Rst-Series ControlKSF · Traditional | 04/16/1980SE |
Questions and answers
When was Test, C-Reative Protein, Latex Slide cleared by the FDA?
Test, C-Reative Protein, Latex Slide (K760035) received a 510(k) decision of Substantially Equivalent on August 3, 1976, 50 days after the submission was received.
What is the product code of K760035?
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.