510(k) K820483
K820483 is an FDA 510(k) premarket notification submitted by Innovative Diagnostic Systems, Inc. for the device "IDA RAPID O2A SYSTEM". The FDA issued a decision of Substantially Equivalent on March 15, 1982. The device falls under product code JSP (Kit, Anaerobic Identification), a Class I device regulated under 21 CFR 866.2660. Innovative Diagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 15, 1982
- Date Received
- February 22, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Kit, Anaerobic Identification
- Device Class
- Class I
- Regulation Number
- 866.2660
- Review Panel
- MI
- Submission Type