510(k) K833062
K833062 is an FDA 510(k) premarket notification submitted by Sterling Biochemical, Inc. for the device "SERUM CHOLINESTERASE REAGENT SET". The FDA issued a decision of Substantially Equivalent on November 25, 1983. The device falls under product code DLI (Acetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase), a Class I device regulated under 21 CFR 862.3240. Sterling Biochemical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 25, 1983
- Date Received
- September 8, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Acetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase
- Device Class
- Class I
- Regulation Number
- 862.3240
- Review Panel
- TX
- Submission Type