510(k) K900517
K900517 is an FDA 510(k) premarket notification submitted by Innovative Diagnostic Systems, Inc. for the device "RAPID NF SYSTEM". The FDA issued a decision of Substantially Equivalent on March 13, 1990. The device falls under product code JSW (Kit, Identification, Glucose Nonfermenter), 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 13, 1990
- Date Received
- February 2, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Kit, Identification, Glucose Nonfermenter
- Device Class
- Class I
- Regulation Number
- 866.2660
- Review Panel
- MI
- Submission Type