510(k) K760821
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 21, 1976
- Date Received
- October 13, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hydrazone Colorimetry, Aldolase
- Device Class
- Class I
- Regulation Number
- 862.1040
- Review Panel
- CH
- Submission Type