510(k) K040407
K040407 is an FDA 510(k) premarket notification submitted by Immunetics, Inc. for the device "QUICKELISA ANTHRAX-PA KIT". The FDA issued a decision of Substantially Equivalent on June 3, 2004. The device falls under product code NRL (Enzyme Linked Immunoabsorbent Assay, Antibody, B. Anthracis), a Class II device regulated under 21 CFR 866.3045. Immunetics, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 3, 2004
- Date Received
- February 17, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enzyme Linked Immunoabsorbent Assay, Antibody, B. Anthracis
- Device Class
- Class II
- Regulation Number
- 866.3045
- Review Panel
- MI
- Submission Type
The elisa assay for antibodies to b. Anthracis is used to detect an immunological response to proteins secreted by b. Anthracis; As an aid in the laboratory diagnosis of anthrax.