510(k) K811189
K811189 is an FDA 510(k) premarket notification submitted by Biodynamics Corp. for the device "CHEMSTRIP L". The FDA issued a decision of Substantially Equivalent on July 27, 1981. The device falls under product code GHD (Test, Leukocyte Alkaline Phosphatase), a Class I device regulated under 21 CFR 864.7660. Biodynamics Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 27, 1981
- Date Received
- April 29, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Test, Leukocyte Alkaline Phosphatase
- Device Class
- Class I
- Regulation Number
- 864.7660
- Review Panel
- HE
- Submission Type