AMIKACIN REAGENT TEST KIT
FDA 510(k) clearance K840647 · decided 1984-04-02
Clearance details
- K-number
- K840647
- Device name
- AMIKACIN REAGENT TEST KIT
- Applicant
- Beckman Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-02-15
- Decision date
- 1984-04-02
- Days to decision
- 47 days
- Clearance type
- Traditional
- Product code
- LDN
- Device class
- 2
- Regulation number
- 862.3035
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Beckman Instruments
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 |
|---|---|---|
| MODIFICATION OF EMIT AND AMIKACIN ASSAY (K833546) | Syva Co. | 1983-12-08 |
| EMIT-AMD AMIKACIN CONTR. (ENZYME IMMUNO (K820440) | Syva Co. | 1982-03-15 |
Recalls involving this device
No recalls on record reference this clearance.