Meloy Immunostat Monoclonal Factor Viii
FDA 510(k) K841708 · Meloy Laboratories, Inc.
510(k) numberK841708
Submission
- Device name
- Meloy Immunostat Monoclonal Factor Viii
- Applicant
- Meloy Laboratories, Inc.
Walker, MI, US - Received
- April 23, 1984
- Decision date
- July 19, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GGP – Test, Qualitative And Quantitative Factor Deficiency
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7290
- Specialty
- Hematology
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More from Instrumentation Laboratory CO
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|---|---|---|
| K852033 | Ss-A(Ro) & Ss-B(La) Antibody AssayDHN · Traditional | 06/21/1985SE |
| K844678 | Meloy Lab-Antinuclear Antibody TEST-HEP-2 Cell CulDHN · Traditional | 01/04/1985SE |
| K842247 | Meloy Autoantibody Test SysDBM · Traditional | 06/26/1984SE |
| K831292 | Anti-Ena TestLKO · Traditional | 07/18/1983SE |
| K820265 | Ana Test (Mouse Liver Substrate)DHN · Traditional | 02/12/1982SE |
| K820005 | Total Hemolytic Complement Test Kit · Traditional | 01/22/1982SE |
| K811178 | Human Igg-Albumin Test KitCJQ · Traditional | 05/15/1981SE |
| K792562 | Immunostat TSH TestJLW · Traditional | 01/16/1980SE |
| K791493 | Anti-Nuclear Antibody TestDHN · Traditional | 09/24/1979SE |
| K791065 | Immunospot TSH TestJLW · Traditional | 07/30/1979SE |
Questions and answers
When was Meloy Immunostat Monoclonal Factor Viii cleared by the FDA?
Meloy Immunostat Monoclonal Factor Viii (K841708) received a 510(k) decision of Substantially Equivalent on July 19, 1984, 87 days after the submission was received.
What is the product code of K841708?
The FDA product code is GGP – Test, Qualitative And Quantitative Factor Deficiency, a Class II (moderate risk) device regulated under 21 CFR 864.7290.