510(k) K881380
K881380 is an FDA 510(k) premarket notification submitted by American Biomedical Products, Inc. for the device "B. FRAGTEX". The FDA issued a decision of Substantially Equivalent on October 6, 1988. The device falls under product code JSP (Kit, Anaerobic Identification), a Class I device regulated under 21 CFR 866.2660.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 6, 1988
- Date Received
- April 1, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Kit, Anaerobic Identification
- Device Class
- Class I
- Regulation Number
- 866.2660
- Review Panel
- MI
- Submission Type