510(k) K942041
K942041 is an FDA 510(k) premarket notification submitted by Meditech for the device "NIDA-5/RT, DRUG OF ABUSE CONTROLS". The FDA issued a decision of Substantially Equivalent on Sep 14, 1994. The device falls under product code DIF (Drug Mixture Control Materials), a Class I device regulated under 21 CFR 862.3280. Meditech has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 14, 1994
- Date Received
- Apr 28, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Drug Mixture Control Materials
- Device Class
- Class I
- Regulation Number
- 862.3280
- Review Panel
- TX
- Submission Type
- 510(k) Exempt