510(k) K961544
K961544 is an FDA 510(k) premarket notification submitted by Consolidated Technologies, Inc. for the device "QUALITROL IGAME CONTROLS, LEVELS 1 AND 2". The FDA issued a decision of Substantially Equivalent on September 24, 1996. The device falls under product code DGR (Whole Human Serum, Antigen, Antiserum, Control), a Class I device regulated under 21 CFR 866.5700. Consolidated Technologies, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 24, 1996
- Date Received
- April 22, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Whole Human Serum, Antigen, Antiserum, Control
- Device Class
- Class I
- Regulation Number
- 866.5700
- Review Panel
- HE
- Submission Type