510(k) K823016
K823016 is an FDA 510(k) premarket notification submitted by Ramco Laboratories, Inc. for the device "CANDIDA DETECTION SYSTEM". The FDA issued a decision of Substantially Equivalent on December 28, 1982. The device falls under product code LHK (Antigen, Id, Candida Albicans), a Class II device regulated under 21 CFR 866.3165. Ramco Laboratories, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 28, 1982
- Date Received
- October 12, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antigen, Id, Candida Albicans
- Device Class
- Class II
- Regulation Number
- 866.3165
- Review Panel
- MI
- Submission Type