510(k) K883703
K883703 is an FDA 510(k) premarket notification submitted by Medical Specialties, Inc. for the device "MSI-CAL 7". The FDA issued a decision of Substantially Equivalent on November 22, 1988. The device falls under product code KRZ (Calibrator For Hemoglobin And Hematocrit Measurement), a Class II device regulated under 21 CFR 864.8165. Medical Specialties, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 22, 1988
- Date Received
- August 30, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Calibrator For Hemoglobin And Hematocrit Measurement
- Device Class
- Class II
- Regulation Number
- 864.8165
- Review Panel
- HE
- Submission Type