Transferrin Nephelometric Assay
FDA 510(k) K772253 · Kallestad Laboratories, Inc.
510(k) numberK772253
Submission
- Device name
- Transferrin Nephelometric Assay
- Applicant
- Kallestad Laboratories, Inc.
Walker, MI, US - Received
- December 9, 1977
- Decision date
- December 22, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DDG – Transferrin, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5880
- Specialty
- Immunology
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| 510(k) | Device | Decision |
|---|---|---|
| K863681 | Pathfinder(Tm) Direct Antigen Detection SystemLJP · Traditional | 12/03/1986SE |
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| K863682 | Pathfinder(Tm) Specimen Collection KitJSM · Traditional | 10/10/1986SE |
| K862743 | Pathfinder(Tm) Respiratory Syncytial VirusGQG · Traditional | 09/29/1986SE |
| K862313 | Kallestad Sm/Rnp Test ReagentLKJ · Traditional | 08/06/1986SE |
| K862710 | Kallestad Ssa/Ssb Ena Test ReagentsLLL · Traditional | 07/29/1986SE |
| K855014 | Quantimetric Plus Calibrator/Control Set aJIX · Traditional | 03/14/1986SE |
| K855010 | Quantimetric Plus Igm Reagent KitDFT · Traditional | 02/28/1986SE |
| K855013 | Quantimetric Plus Support PackDEH · Traditional | 02/26/1986SE |
| K855012 | Quantimetric Plus C4 Reagent KitDBI · Traditional | 02/26/1986SE |
Questions and answers
When was Transferrin Nephelometric Assay cleared by the FDA?
Transferrin Nephelometric Assay (K772253) received a 510(k) decision of Substantially Equivalent on December 22, 1977, 13 days after the submission was received.
What is the product code of K772253?
The FDA product code is DDG – Transferrin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5880.