DISPO FIBRIN PIPET TIPS B4182-2
FDA 510(k) clearance K820532 · decided 1982-04-08
Clearance details
- K-number
- K820532
- Device name
- DISPO FIBRIN PIPET TIPS B4182-2
- Applicant
- American Scientific Products
- Decision
- Substantially Equivalent
- Date received
- 1982-03-02
- Decision date
- 1982-04-08
- Days to decision
- 37 days
- Clearance type
- Traditional
- Product code
- GIE
- Device class
- 2
- Regulation number
- 864.5400
- 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 |
|---|---|---|
| B4182-1 (K820533) | American Scientific Products | 1982-04-08 |
Recalls involving this device
No recalls on record reference this clearance.