510(k) K885091
K885091 is an FDA 510(k) premarket notification submitted by Technalysis, Inc. for the device "HEMAVIEW DARKFIELD MICROSCOPE SYSTEM". The FDA issued a decision of Substantially Equivalent on June 13, 1989. The device falls under product code IBM (Microscope, Phase Contrast), a Class I device regulated under 21 CFR 864.3600. Technalysis, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 13, 1989
- Date Received
- December 12, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Microscope, Phase Contrast
- Device Class
- Class I
- Regulation Number
- 864.3600
- Review Panel
- PA
- Submission Type