510(k) K780182
K780182 is an FDA 510(k) premarket notification submitted by New England Nuclear for the device "TOBRAMYCIN 125I RIA KIT". The FDA issued a decision of Substantially Equivalent on February 13, 1978. The device falls under product code DID (Bacillus Subtilis Microbiology Assay, Tobramycin), a Class II device regulated under 21 CFR 862.3900. New England Nuclear has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 13, 1978
- Date Received
- February 3, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bacillus Subtilis Microbiology Assay, Tobramycin
- Device Class
- Class II
- Regulation Number
- 862.3900
- Review Panel
- TX
- Submission Type