510(k) K894416
K894416 is an FDA 510(k) premarket notification submitted by Reagents Applications, Inc. for the device "RAICHEM(TM) SPIA(TM) IGG REAGENTS". The FDA issued a decision of Substantially Equivalent on August 1, 1989. The device falls under product code KTO (Reagent, Immunoassay, Igg), a Class I device regulated under 21 CFR 866.5530. Reagents Applications, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 1, 1989
- Date Received
- July 17, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Reagent, Immunoassay, Igg
- Device Class
- Class I
- Regulation Number
- 866.5530
- Review Panel
- IM
- Submission Type