510(k) K914953
K914953 is an FDA 510(k) premarket notification submitted by Stellar Bio Systems, Inc. for the device "IFA FOR CHLAMYDIA TRACHOMATIS IGG ANTIBODY". The FDA issued a decision of Substantially Equivalent on February 19, 1992. The device falls under product code LKI (Antisera, Fluorescent, Chlamydia Spp.), a Class I device regulated under 21 CFR 866.3120. Stellar Bio Systems, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 19, 1992
- Date Received
- November 5, 1991
- 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