510(k) K884693
K884693 is an FDA 510(k) premarket notification submitted by Biomedical Research & Development Laboratories, Inc. for the device "UNIVERSAL(TM) ION SELECT ELECTRODE STANDARDS". The FDA issued a decision of Substantially Equivalent on December 15, 1988. The device falls under product code JIX (Calibrator, Multi-Analyte Mixture), a Class II device regulated under 21 CFR 862.1150. Biomedical Research & Development Laboratories, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 15, 1988
- Date Received
- November 9, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Calibrator, Multi-Analyte Mixture
- Device Class
- Class II
- Regulation Number
- 862.1150
- Review Panel
- CH
- Submission Type