510(k) K931206
K931206 is an FDA 510(k) premarket notification submitted by Medical Laboratory Automation Systems, Inc. for the device "ELECTRA 1600C AUTOMATIC COAGULATION TIMER". The FDA issued a decision of Substantially Equivalent on August 23, 1993. The device falls under product code GKP (Instrument, Coagulation, Automated), a Class II device regulated under 21 CFR 864.5400. Medical Laboratory Automation Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 23, 1993
- Date Received
- March 10, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Coagulation, Automated
- Device Class
- Class II
- Regulation Number
- 864.5400
- Review Panel
- HE
- Submission Type