510(k) K871486
K871486 is an FDA 510(k) premarket notification submitted by Windsor Laboratories, Inc. for the device "(FPIA) ASSAY BUFFER". The FDA issued a decision of Substantially Equivalent on May 8, 1987. The device falls under product code JJF (Analyzer, Chemistry, Micro, For Clinical Use), a Class I device regulated under 21 CFR 862.2170. Windsor Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 8, 1987
- Date Received
- April 15, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Analyzer, Chemistry, Micro, For Clinical Use
- Device Class
- Class I
- Regulation Number
- 862.2170
- Review Panel
- CH
- Submission Type