510(k) K852554
K852554 is an FDA 510(k) premarket notification submitted by Microwave Development, Inc. for the device "SRT-SYSTEM". The FDA issued a decision of Substantially Equivalent on July 18, 1985. The device falls under product code JPH (Test, Erythrocyte Sedimentation Rate), a Class I device regulated under 21 CFR 864.6700.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 18, 1985
- Date Received
- June 17, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Test, Erythrocyte Sedimentation Rate
- Device Class
- Class I
- Regulation Number
- 864.6700
- Review Panel
- HE
- Submission Type