510(k) K861890
K861890 is an FDA 510(k) premarket notification submitted by Richard-Allan Medical Ind., Inc. for the device "100%, 95%, 80% & 70% DEHYDRANT CUSTOM BLEND NO. 2". The FDA issued a decision of Substantially Equivalent on June 3, 1986. The device falls under product code PPM (General Purpose Reagent), a Class I device regulated under 21 CFR 864.4010. Richard-Allan Medical Ind., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 3, 1986
- Date Received
- May 16, 1986
- 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.