FREEZE DRIED FICIN
FDA 510(k) clearance K813404 · decided 1982-02-10
Clearance details
- K-number
- K813404
- Device name
- FREEZE DRIED FICIN
- Applicant
- Biological Corp. of America
- Decision
- Substantially Equivalent
- Date received
- 1981-12-07
- Decision date
- 1982-02-10
- Days to decision
- 65 days
- Clearance type
- Traditional
- Product code
- KSK
- Device class
- 2
- Regulation number
- 864.9400
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Biological Corp. of America
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 |
|---|---|---|
| GAMMA CHLOROQUINE DIPHOSPHATE SOLUTION (K813342) | Gamma Biologicals, Inc. | 1982-03-04 |
| FREEZE DRIED PAPAIN (K810803) | Biological Corp. of America | 1981-07-21 |
| AUTOMATED ENZYME (K780962) | Hyland Therapeutic Div., Travenol Laboratories | 1978-07-27 |
| AUTOZYME (K760123) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1976-07-20 |
Recalls involving this device
No recalls on record reference this clearance.