510(k) K936066
K936066 is an FDA 510(k) premarket notification submitted by Nova Biomedical Corp. for the device "STAT PROFILE PLUS 9 ANALYZER". The FDA issued a decision of Substantially Equivalent on March 9, 1995. The device falls under product code KHP (Acid, Lactic, Enzymatic Method), a Class I device regulated under 21 CFR 862.1450. Nova Biomedical Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 9, 1995
- Date Received
- December 21, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Acid, Lactic, Enzymatic Method
- Device Class
- Class I
- Regulation Number
- 862.1450
- Review Panel
- CH
- Submission Type