510(k) K962053
K962053 is an FDA 510(k) premarket notification submitted by American Laboratory Products Co., Ltd. for the device "ORGENTEC ANTI-JO-1 ELISA". The FDA issued a decision of Substantially Equivalent on November 15, 1996. The device falls under product code LJM (Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls), a Class II device regulated under 21 CFR 866.5100. American Laboratory Products Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 15, 1996
- Date Received
- May 28, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
- Device Class
- Class II
- Regulation Number
- 866.5100
- Review Panel
- IM
- Submission Type