AMIZYME-LEISHMANIA SPP. TEST KIT
FDA 510(k) clearance K842526 · decided 1984-08-28
Clearance details
- K-number
- K842526
- Device name
- AMIZYME-LEISHMANIA SPP. TEST KIT
- Applicant
- Amico Lab, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-06-28
- Decision date
- 1984-08-28
- Days to decision
- 61 days
- Clearance type
- Traditional
- Product code
- LOO
- Device class
- 1
- Regulation number
- 866.3870
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Amico Lab
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 |
|---|---|---|
| KALAZAR DETECT (K023483) | Inbios Intl., Inc. | 2003-05-06 |
Recalls involving this device
No recalls on record reference this clearance.