WESTERGREN DISPETTE FOR ESR
FDA 510(k) clearance K831195 · decided 1983-05-09
Clearance details
- K-number
- K831195
- Device name
- WESTERGREN DISPETTE FOR ESR
- Applicant
- Ulster Scientific, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-04-12
- Decision date
- 1983-05-09
- Days to decision
- 27 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
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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 |
|---|---|---|
| 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 |
| SEDIPLAST (K840500) | Precision Technology, Inc. | 1984-02-21 |
| 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.