510(k) K833276
K833276 is an FDA 510(k) premarket notification submitted by Supelco, Inc. for the device "DRUG STANDARDS". The FDA issued a decision of Substantially Equivalent on January 1, 1984. The device falls under product code DKB (Calibrators, Drug Mixture), a Class II device regulated under 21 CFR 862.3200. Supelco, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 1, 1984
- Date Received
- September 22, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Calibrators, Drug Mixture
- Device Class
- Class II
- Regulation Number
- 862.3200
- Review Panel
- TX
- Submission Type