Lumatag(Tm) Ferritin Chemiluminescence Immunomet.
FDA 510(k) K901075 · London Diagnostics, Inc.
510(k) numberK901075
Submission
- Device name
- Lumatag(Tm) Ferritin Chemiluminescence Immunomet.
- Applicant
- London Diagnostics, Inc.
Eden Prairie, MN, US - Received
- March 8, 1990
- Decision date
- April 2, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DBF – Ferritin, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5340
- Specialty
- Immunology
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More from Reference Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K914835 | Lumatag Free T4 Chemiluminescence AssayCEC · Traditional | 12/17/1991SE |
| K911985 | Lumatag T4 Chemiluminescence AssayCDX · Traditional | 08/02/1991SE |
| K912858 | London Diagnostics Lumatag(R) HGH Chem Immun AssayCFL · Traditional | 07/30/1991SE |
| K905814 | Lumatag(R) FSH Chemiluminescence Immunometri AssayCGJ · Traditional | 02/04/1991SE |
| K904458 | Lumatag(Tm) Prolactin Diagnostic Kit/ModificationCFT · Traditional | 10/12/1990SE |
| K903130 | London Diagnostics Lumatag(Tm) Intact PTH AssayCEW · Traditional | 09/25/1990SE |
| K903195 | London Diagnostics Lumatag (R) Ige Chem. Imm AssayDGC · Traditional | 08/02/1990SE |
| K902443 | Lumatag(Tm) LH Diagnostic KitCEP · Traditional | 08/02/1990SE |
| K901484 | Lumatag(Tm) HCG Chemiluminescence ImmunometricJHI · Traditional | 05/01/1990SE |
| K881443 | Lumatag(Tm) TSH Chemiluminescence Immuno. AssayJLW · Traditional | 05/27/1988SE |
Questions and answers
When was Lumatag(Tm) Ferritin Chemiluminescence Immunomet. cleared by the FDA?
Lumatag(Tm) Ferritin Chemiluminescence Immunomet. (K901075) received a 510(k) decision of Substantially Equivalent on April 2, 1990, 25 days after the submission was received.
What is the product code of K901075?
The FDA product code is DBF – Ferritin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5340.