510(k) K973995
K973995 is an FDA 510(k) premarket notification submitted by Randox Laboratories, Ltd. for the device "RANDOX BILIRUBIN". The FDA issued a decision of Substantially Equivalent on December 8, 1997. The device falls under product code GIG (Hemoglobinometer), a Class II device regulated under 21 CFR 864.7500. Randox Laboratories, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 8, 1997
- Date Received
- October 21, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hemoglobinometer
- Device Class
- Class II
- Regulation Number
- 864.7500
- Review Panel
- HE
- Submission Type