510(k) K990928
K990928 is an FDA 510(k) premarket notification submitted by Bio-Rad for the device "LYPHOCHECK URINE METALS CONTROL, ITEM NO.400, 405". The FDA issued a decision of Substantially Equivalent on April 16, 1999. The device falls under product code DIE (Heavy Metals Control Materials), a Class I device regulated under 21 CFR 862.3280. Bio-Rad has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 16, 1999
- Date Received
- March 19, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Heavy Metals Control Materials
- Device Class
- Class I
- Regulation Number
- 862.3280
- Review Panel
- TX
- Submission Type