PELICALSS HUMAN IGG SUBCLASS NEPHLOMETRIC ARRAY KIT
FDA 510(k) clearance K982023 · decided 1998-09-04
Clearance details
- K-number
- K982023
- Device name
- PELICALSS HUMAN IGG SUBCLASS NEPHLOMETRIC ARRAY KIT
- Applicant
- Inova Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-06-09
- Decision date
- 1998-09-04
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- DAS
- Device class
- 1
- Regulation number
- 866.5530
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| HUMAN IGG SUBCLASSES NEPHELOMETRIC BNA KIT (K944876) | Research Diagnostics, Inc. | 1994-12-15 |
| HUMAN IGG SUBCLASSES ELISA COMBI KIT (K943098) | Research Diagnostics, Inc. | 1994-09-07 |
| HUMAN IGG SUBCLASSES RID COMBI KIT (MODIFICATION) (K943205) | Research Diagnostics, Inc. | 1994-09-07 |
| HUMAN (IGG) SUBCLASS (EIA) KIT (K895600) | The Binding Site, Ltd. | 1989-11-08 |
| ANTISERUM TO HUMAN IG G FC FRAGMENTS (K790708) | Kent Laboratories, Inc. | 1979-08-22 |
| ANTISERUM TO HUMAN FC (K790715) | Kent Laboratories, Inc. | 1979-08-16 |
| AMINOGLYCOSIDE CONTROLS (K761156) | Supelco, Inc. | 1976-12-09 |
Recalls involving this device
No recalls on record reference this clearance.