510(k) K915829
K915829 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "IL TEST(TM) HAPTOGLOBIN (HPT)". The FDA issued a decision of Substantially Equivalent on July 29, 1992. The device falls under product code DAD (Haptoglobin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5460. Instrumentation Laboratory CO has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 29, 1992
- Date Received
- December 30, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Haptoglobin, Antigen, Antiserum, Control
- Device Class
- Class II
- Regulation Number
- 866.5460
- Review Panel
- IM
- Submission Type