510(k) K961042
K961042 is an FDA 510(k) premarket notification submitted by Dade Microscan, Inc. for the device "MICROSCAN RAPID GRAM-NEGATIVE INDENTIFICATION TYPE 3 PANEL". The FDA issued a decision of Substantially Equivalent on May 30, 1996. The device falls under product code LRH (Instrument For Auto Reader Of Overnight Microorganism Identification System), a Class I device regulated under 21 CFR 866.2660. Dade Microscan, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 30, 1996
- Date Received
- March 14, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument For Auto Reader Of Overnight Microorganism Identification System
- Device Class
- Class I
- Regulation Number
- 866.2660
- Review Panel
- MI
- Submission Type