510(k) K850158
K850158 is an FDA 510(k) premarket notification submitted by Clinical Sciences, Inc. for the device "CHLAMYDIA FLUORO-KIT 1680". The FDA issued a decision of Substantially Equivalent on March 21, 1985. The device falls under product code LJP (Antiserum, Fluorescent, Chlamydia Trachomatis), a Class I device regulated under 21 CFR 866.3120. Clinical Sciences, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 21, 1985
- Date Received
- January 15, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antiserum, Fluorescent, Chlamydia Trachomatis
- Device Class
- Class I
- Regulation Number
- 866.3120
- Review Panel
- MI
- Submission Type