Radioassay, Control Serum I, II, III
FDA 510(k) K790298 · Kallestad Laboratories, Inc.
510(k) numberK790298
Submission
- Device name
- Radioassay, Control Serum I, II, III
- Applicant
- Kallestad Laboratories, Inc.
Mchenry, IL, US - Received
- February 12, 1979
- Decision date
- April 4, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DGR – Whole Human Serum, Antigen, Antiserum, Control
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.5700
- Specialty
- Immunology
Other 510(k)s with product code DGR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K961544 | Qualitrol Igame Controls, Levels 1 and 2DGR · Traditional | Consolidated Technologies, Inc. | 09/24/1996SE |
| K902220 | Precipath(R) Im Normal & Abnormal Immuno. ControlDGR · Traditional | Boehringer Mannheim Corp. | 09/05/1990SE |
| K865014 | Liquichek Immunology Control (Human) Levels I & IIDGR · Traditional | Bio-Rad | 01/09/1987SE |
| K781355 | Ics Normal Control SerumDGR · Traditional | Beckman Instruments, Inc. | 08/31/1978SE |
More from Beckman Instruments, 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 Radioassay, Control Serum I, II, III cleared by the FDA?
Radioassay, Control Serum I, II, III (K790298) received a 510(k) decision of Substantially Equivalent on April 4, 1979, 51 days after the submission was received.
What is the product code of K790298?
The FDA product code is DGR – Whole Human Serum, Antigen, Antiserum, Control, a Class I (low risk) device regulated under 21 CFR 866.5700.