510(k) K913186
K913186 is an FDA 510(k) premarket notification submitted by Intl. Bioclinical, Inc. for the device "INNOFLUOR(TM) DIGITOXIN CALIBRATOR SET". The FDA issued a decision of Substantially Equivalent on August 30, 1991. The device falls under product code DLJ (Calibrators, Drug Specific), a Class II device regulated under 21 CFR 862.3200. Intl. Bioclinical, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 30, 1991
- Date Received
- July 18, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Calibrators, Drug Specific
- Device Class
- Class II
- Regulation Number
- 862.3200
- Review Panel
- TX
- Submission Type