510(k) K963911
K963911 is an FDA 510(k) premarket notification submitted by American Laboratory Products Co., Ltd. for the device "ALPCO/MERCODIA INSULIN ELISA". The FDA issued a decision of Substantially Equivalent on November 1, 1996. The device falls under product code CFP (Radioimmunoassay, Immunoreactive Insulin), a Class I device regulated under 21 CFR 862.1405. American Laboratory Products Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 1, 1996
- Date Received
- September 30, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioimmunoassay, Immunoreactive Insulin
- Device Class
- Class I
- Regulation Number
- 862.1405
- Review Panel
- CH
- Submission Type