510(k) K926443
K926443 is an FDA 510(k) premarket notification submitted by Roche Diagnostic Systems, Inc. for the device "COBAS(R)-FP REAGENTS FOR T-UPTAKE/CALIBRATORS". The FDA issued a decision of Substantially Equivalent on May 20, 1993. The device falls under product code KHQ (Radioassay, Triiodothyronine Uptake), a Class II device regulated under 21 CFR 862.1715. Roche Diagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 20, 1993
- Date Received
- December 23, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioassay, Triiodothyronine Uptake
- Device Class
- Class II
- Regulation Number
- 862.1715
- Review Panel
- CH
- Submission Type