510(k) K831131
K831131 is an FDA 510(k) premarket notification submitted by Case Instruments for the device "CASE WRIGHT-GIEMSA STAIN PAK". The FDA issued a decision of Substantially Equivalent on June 8, 1983. The device falls under product code HYF (Giemsa Stain), a Class I device regulated under 21 CFR 864.1850.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 8, 1983
- Date Received
- April 6, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Giemsa Stain
- Device Class
- Class I
- Regulation Number
- 864.1850
- Review Panel
- PA
- Submission Type