Pelicalss Human Igg Subclass Nephlometric Array Kit
FDA 510(k) K982023 · Inova Diagnostics, Inc.
510(k) numberK982023
Submission
- Device name
- Pelicalss Human Igg Subclass Nephlometric Array Kit
- Applicant
- Inova Diagnostics, Inc.
San Diego, CA, US - Received
- June 9, 1998
- Decision date
- September 4, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DAS – Igg (Fc Fragment Specific), Antigen, Antiserum, Control
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.5530
- Specialty
- Immunology
Other 510(k)s with product code DAS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K944876 | Human Igg Subclasses Nephelometric Bna KitDAS · Traditional | Research Diagnostics, Inc. | 12/15/1994SE |
| K943205 | Human Igg Subclasses Rid Combi Kit (Modification)DAS · Traditional | Research Diagnostics, Inc. | 09/07/1994SE |
| K943098 | Human Igg Subclasses Elisa Combi KitDAS · Traditional | Research Diagnostics, Inc. | 09/07/1994SE |
| K895600 | Human (Igg) Subclass (Eia) KitDAS · Traditional | The Binding Site, Ltd. | 11/08/1989SE |
| K790708 | Antiserum to Human Ig G FC FragmentsDAS · Traditional | Kent Laboratories, Inc. | 08/22/1979SE |
| K790715 | Antiserum to Human FCDAS · Traditional | Kent Laboratories, Inc. | 08/16/1979SE |
| K761156 | Aminoglycoside ControlsDAS · Traditional | Supelco, Inc. | 12/09/1976SE |
More from Supelco, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K243979 | Aptiva APS IgA ReagentMSV · Traditional | 02/06/2026SE |
| K223093 | Aptiva APS IgG Reagent; Aptiva APS IgM ReagentMID · Traditional | 12/17/2024SE |
| K213403 | Aptiva CTD Essential ReagentLLL · Traditional | 09/29/2023SE |
| K200230 | Aptiva Celiac Disease IgG ReagentMVM · Traditional | 08/26/2021SE |
| K193604 | Aptiva Celiac Disease IgA ReagentMVM · Traditional | 06/16/2021SE |
| K192916 | NOVA Lite DAPI dsDNA Crithidia luciliae KitKTL · Traditional | 12/11/2020SE |
| K190088 | QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA ReagentsDHR · Traditional | 04/17/2019SE |
| K180971 | QUANTA Flash Calprotectin and Fecal Extraction DeviceNXO · Traditional | 10/16/2018SE |
| K180975 | QUANTA Flash HMGCR ReagentsLLL · Traditional | 06/25/2018SE |
| K170993 | QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash…NXO · Traditional | 12/22/2017SE |
Questions and answers
When was Pelicalss Human Igg Subclass Nephlometric Array Kit cleared by the FDA?
Pelicalss Human Igg Subclass Nephlometric Array Kit (K982023) received a 510(k) decision of Substantially Equivalent on September 4, 1998, 87 days after the submission was received.
What is the product code of K982023?
The FDA product code is DAS – Igg (Fc Fragment Specific), Antigen, Antiserum, Control, a Class I (low risk) device regulated under 21 CFR 866.5530.