510(k) K891761
K891761 is an FDA 510(k) premarket notification submitted by Gds Diagnostics for the device "GDS ENZYMATIC THEOPHYLLINE REAGENT". The FDA issued a decision of Substantially Equivalent on May 16, 1989. The device falls under product code LCY (U.V. Spectrometry, Theophylline), a Class II device regulated under 21 CFR 862.3880. Gds Diagnostics has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 16, 1989
- Date Received
- March 24, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- U.V. Spectrometry, Theophylline
- Device Class
- Class II
- Regulation Number
- 862.3880
- Review Panel
- TX
- Submission Type