ADVANCE TM EMIT(R) & TM AMIKACIN ASSAY
FDA 510(k) clearance K823370 · decided 1982-12-03
Clearance details
- K-number
- K823370
- Device name
- ADVANCE TM EMIT(R) & TM AMIKACIN ASSAY
- Applicant
- Syva Co.
- Decision
- Substantially Equivalent
- Date received
- 1982-11-10
- Decision date
- 1982-12-03
- Days to decision
- 23 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 Syva Co.
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 |
| KENAMYCIN FLUORESCENT IMMUNOASSAY FIA (K823062) | American Diagnostic Corp. | 1982-11-10 |
| TDX KENAMYCIN (K822808) | Abbott Laboratories | 1982-10-08 |
| RIA KIT, KANAMYCIN (K782125) | Diagnostic Products Corp. | 1979-01-10 |
| KANAMYCIN RIA (K772038) | Monitor Science Corp. | 1978-01-12 |
Recalls involving this device
No recalls on record reference this clearance.