510(k) K903924
K903924 is an FDA 510(k) premarket notification submitted by Biotrack, Inc. for the device "BIOTRACK THEOPHYLLINE QUALITY CONTROLS". The FDA issued a decision of Substantially Equivalent on September 17, 1990. The device falls under product code LAW (Theophylline Control Materials), a Class I device regulated under 21 CFR 862.3280. Biotrack, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 17, 1990
- Date Received
- August 24, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Theophylline Control Materials
- Device Class
- Class I
- Regulation Number
- 862.3280
- Review Panel
- TX
- Submission Type