LECTIN-A
FDA 510(k) clearance K820368 · decided 1982-04-14
Clearance details
- K-number
- K820368
- Device name
- LECTIN-A
- Applicant
- American Dade
- Decision
- Substantially Equivalent
- Date received
- 1982-02-09
- Decision date
- 1982-04-14
- Days to decision
- 64 days
- Clearance type
- Traditional
- Product code
- KSI
- Device class
- 2
- Regulation number
- 864.9550
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- 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 |
|---|---|---|
| LECTIN H (K813413) | American Dade | 1982-03-04 |
| POLY-LEC SYSTEM (K792582) | Gamma Biologicals, Inc. | 1980-01-16 |
| GAMMA ARACHIS HYPOGEA LECTIN (K792583) | Gamma Biologicals, Inc. | 1980-01-16 |
Recalls involving this device
No recalls on record reference this clearance.