510(k) K852554
- Device
- Srt-system
- Applicant
- MICROWAVE DEVELOPMENT, INC.
- 510(k) number
- K852554
- Product code
- JPH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-07-18
- Date received
- 1985-06-17
- 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#
- Contact
- TOMAS WEHTJE
- Address
- 13 Arcadia Rd. Old Greenwich CT US 06870 06870
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 |
| 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 |
| K823368 | DADE ESR KIT | American Dade | 1982-12-28 |