510(k) K831619
K831619 is an FDA 510(k) premarket notification submitted by Omega Medical Diagnostics for the device "SODIUM HYPOCHLORITE 7%". The FDA issued a decision of Substantially Equivalent on July 28, 1983. The device falls under product code PPM (General Purpose Reagent), a Class I device regulated under 21 CFR 864.4010. Omega Medical Diagnostics has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 28, 1983
- Date Received
- May 19, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- General Purpose Reagent
- Device Class
- Class I
- Regulation Number
- 864.4010
- Review Panel
- PA
- Submission Type
A general purpose reagent is a chemical reagent that has general laboratory application, that is used to collect, prepare, and examine specimens from the human body for diagnostic purposes, and that is not labeled or otherwise intended for a specific diagnostic application. It may be either an individual substance, or multiple substances reformulated, which, when combined with or used in conjunction with an appropriate analyte specific reagent (ASR) and other general purpose reagents, is part of a diagnostic test procedure or system constituting a finished in vitro diagnostic (IVD) test.