510(k) K925916
K925916 is an FDA 510(k) premarket notification submitted by Biomerieux Vitek, Inc. for the device "VITEK RAPID CALL-GRAM POSITIVE IDENTIFICATION CARD". The FDA issued a decision of Substantially Equivalent on Mar 23, 1993. The device falls under product code LQL (Gram Positive Identification Panel), a Class I device regulated under 21 CFR 866.2660. Biomerieux Vitek, Inc. has 48 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 23, 1993
- Date Received
- Nov 23, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Gram Positive Identification Panel
- Device Class
- Class I
- Regulation Number
- 866.2660
- Review Panel
- MI
- Submission Type
- 510(k) Exempt