510(k) K771024
K771024 is an FDA 510(k) premarket notification submitted by American Monitor Corp. for the device "CHOLINESTERASE REAGENT SYSTEM". The FDA issued a decision of Substantially Equivalent on July 15, 1977. The device falls under product code DLI (Acetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase), a Class I device regulated under 21 CFR 862.3240. American Monitor Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 15, 1977
- Date Received
- June 8, 1977
- 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