510(k) K905531
K905531 is an FDA 510(k) premarket notification submitted by Immco Diagnostics, Inc. for the device "LUPUS(LE)-LATEX TEST". The FDA issued a decision of Substantially Equivalent on January 25, 1991. The device falls under product code LKI (Antisera, Fluorescent, Chlamydia Spp.), a Class I device regulated under 21 CFR 866.3120. Immco Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 25, 1991
- Date Received
- December 10, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antisera, Fluorescent, Chlamydia Spp.
- Device Class
- Class I
- Regulation Number
- 866.3120
- Review Panel
- MI
- Submission Type