510(k) K853049
K853049 is an FDA 510(k) premarket notification submitted by Simmler, Inc. for the device "ALBUMIN REAGENT FOR ASTRA 8 AUTO STAT/ROUT ANALYZE". The FDA issued a decision of Substantially Equivalent on Aug 2, 1985. The device falls under product code CIX (Bromcresol Green Dye-Binding, Albumin), a Class II device regulated under 21 CFR 862.1035. Simmler, Inc. has 22 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 2, 1985
- Date Received
- Jul 19, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bromcresol Green Dye-Binding, Albumin
- Device Class
- Class II
- Regulation Number
- 862.1035
- Review Panel
- CH
- Submission Type
- 510(k)