510(k) K972756
K972756 is an FDA 510(k) premarket notification submitted by Accumed Intl., Inc. for the device "MODIFICATION OF EST CULTURE SYSTEM II - MYCO". The FDA issued a decision of Substantially Equivalent on Aug 1, 1997. The device falls under product code MDB (System, Blood Culturing), a Class I device regulated under 21 CFR 866.2560. Accumed Intl., Inc. has 11 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 1, 1997
- Date Received
- May 30, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- System, Blood Culturing
- Device Class
- Class I
- Regulation Number
- 866.2560
- Review Panel
- MI
- Submission Type
- 510(k)