510(k) K903396
K903396 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "IL T UPTAKE ASSAY SYSTEM". The FDA issued a decision of Substantially Equivalent on October 12, 1990. The device falls under product code KHQ (Radioassay, Triiodothyronine Uptake), a Class II device regulated under 21 CFR 862.1715. Instrumentation Laboratory CO has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 12, 1990
- Date Received
- July 27, 1990
- 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