AMINOGLYCOSIDE CONTROLS
FDA 510(k) clearance K761156 · decided 1976-12-09
Clearance details
- K-number
- K761156
- Device name
- AMINOGLYCOSIDE CONTROLS
- Applicant
- Supelco, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1976-11-29
- Decision date
- 1976-12-09
- Days to decision
- 10 days
- Clearance type
- Traditional
- Product code
- DAS
- Device class
- 1
- Regulation number
- 866.5530
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Mchenry, IL, 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 |
|---|---|---|
| PELICALSS HUMAN IGG SUBCLASS NEPHLOMETRIC ARRAY KIT (K982023) | Inova Diagnostics, Inc. | 1998-09-04 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.