510(k) K983387
K983387 is an FDA 510(k) premarket notification submitted by Roche Diagnostic Systems, Inc. for the device "ONTRAK TESTCUP AND TESTSTIK CONTROLS". The FDA issued a decision of Substantially Equivalent on October 9, 1998. The device falls under product code DIF (Drug Mixture Control Materials), a Class I device regulated under 21 CFR 862.3280. Roche Diagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 9, 1998
- Date Received
- September 25, 1998
- 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