Fluorescein Conjugated
FDA 510(k) K772128 · Kallestad Laboratories, Inc.
510(k) numberK772128
Submission
- Device name
- Fluorescein Conjugated
- Applicant
- Kallestad Laboratories, Inc.
Mchenry, IL, US - Received
- November 11, 1977
- Decision date
- November 22, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DCE – Fab, Antigen, Antiserum, Control
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.5520
- Specialty
- Immunology
Other 510(k)s with product code DCE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K781951 | Antisera, Rhodamine Conjugated FragmentDCE · Traditional | Kallestad Laboratories, Inc. | 02/16/1979SE |
More from Kallestad Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K863681 | Pathfinder(Tm) Direct Antigen Detection SystemLJP · Traditional | 12/03/1986SE |
| K862917 | Pathfinder Rotavirus ChemiluminescentLIQ · Traditional | 10/22/1986SE |
| 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 Fluorescein Conjugated cleared by the FDA?
Fluorescein Conjugated (K772128) received a 510(k) decision of Substantially Equivalent on November 22, 1977, 11 days after the submission was received.
What is the product code of K772128?
The FDA product code is DCE – Fab, Antigen, Antiserum, Control, a Class I (low risk) device regulated under 21 CFR 866.5520.