510(k) K823368
- Device
- Dade Esr Kit
- Applicant
- AMERICAN DADE
- 510(k) number
- K823368
- Product code
- JPH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-12-28
- Date received
- 1982-11-10
- Regulation
- 864.6700
- Classification name
- Test, Erythrocyte Sedimentation Rate
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3029895090
- 1950302
- 9617475
- 3011287770
- 9615056
- 3024820199
- 9614769
- 3018126397
- 3010352064
- 3010194621
- 3010280735
- 2435505
- 2244900
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JPH#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K871076 | WINPETTE | Ulster Scientific, Inc. | 1987-03-23 |
| K860899 | DISPETTE II | Ulster Scientific, Inc. | 1986-04-14 |
| K852554 | SRT-SYSTEM | Microwave Development, Inc. | 1985-07-18 |
| K840500 | SEDIPLAST | Precision Technology, Inc. | 1984-02-21 |
| K831195 | WESTERGREN DISPETTE FOR ESR | Ulster Scientific, Inc. | 1983-05-09 |
| K823761 | ERYTHROCYTE & STAND SEDIMENT. RATE TUBE | Cordis Corp. | 1983-01-21 |