RIA KIT, KANAMYCIN
FDA 510(k) clearance K782125 · decided 1979-01-10
Clearance details
- K-number
- K782125
- Device name
- RIA KIT, KANAMYCIN
- Applicant
- Diagnostic Products Corp.
- Decision
- Substantially Equivalent
- Date received
- 1978-12-27
- Decision date
- 1979-01-10
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- KJI
- Device class
- 2
- Regulation number
- 862.3520
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Diagnostic Products Corp.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| AMES TDA KANAMYCIN TEST-CONTROL SERUM (K832769) | Miles Laboratories, Inc. | 1983-09-29 |
| ADVANCE TM EMIT(R) & TM AMIKACIN ASSAY (K823370) | Syva Co. | 1982-12-03 |
| KENAMYCIN FLUORESCENT IMMUNOASSAY FIA (K823062) | American Diagnostic Corp. | 1982-11-10 |
| TDX KENAMYCIN (K822808) | Abbott Laboratories | 1982-10-08 |
| KANAMYCIN RIA (K772038) | Monitor Science Corp. | 1978-01-12 |
Recalls involving this device
No recalls on record reference this clearance.