510(k) K972706
K972706 is an FDA 510(k) premarket notification submitted by Bayer Corp. for the device "CLINITEK MICROALBUMIN REAGENT STRIPS". The FDA issued a decision of Substantially Equivalent on September 9, 1997. The device falls under product code CJG (Tetrabromo-M-Cresolsulfonphthalein, Albumin), a Class II device regulated under 21 CFR 862.1035. Bayer Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 9, 1997
- Date Received
- July 21, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tetrabromo-M-Cresolsulfonphthalein, Albumin
- Device Class
- Class II
- Regulation Number
- 862.1035
- Review Panel
- CH
- Submission Type