510(k) K882149
K882149 is an FDA 510(k) premarket notification submitted by Utah Bioresearch, Inc. for the device "MINIFUGE, MODEL 70". The FDA issued a decision of Substantially Equivalent on July 1, 1988. The device falls under product code GPG (Antigen, Latex Agglutination, Trichinella Spiralis), a Class I device regulated under 21 CFR 866.3850.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 1, 1988
- Date Received
- May 23, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antigen, Latex Agglutination, Trichinella Spiralis
- Device Class
- Class I
- Regulation Number
- 866.3850
- Review Panel
- MI
- Submission Type