SEDIPLAST
FDA 510(k) clearance K840500 · decided 1984-02-21
Clearance details
- K-number
- K840500
- Device name
- SEDIPLAST
- Applicant
- Precision Technology, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-02-06
- Decision date
- 1984-02-21
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- JPH
- Device class
- 1
- Regulation number
- 864.6700
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Precision Technology
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 |
|---|---|---|
| WINPETTE (K871076) | Ulster Scientific, Inc. | 1987-03-23 |
| DISPETTE II (K860899) | Ulster Scientific, Inc. | 1986-04-14 |
| SRT-SYSTEM (K852554) | Microwave Development, Inc. | 1985-07-18 |
| WESTERGREN DISPETTE FOR ESR (K831195) | Ulster Scientific, Inc. | 1983-05-09 |
| ERYTHROCYTE & STAND SEDIMENT. RATE TUBE (K823761) | Cordis Corp. | 1983-01-21 |
| DADE ESR KIT (K823368) | American Dade | 1982-12-28 |
Recalls involving this device
No recalls on record reference this clearance.