510(k) K931257
K931257 is an FDA 510(k) premarket notification submitted by Gds Diagnostics for the device "ACETASITE". The FDA issued a decision of Substantially Equivalent on July 8, 1993. The device falls under product code LDP (Colorimetry, Acetaminophen), a Class II device regulated under 21 CFR 862.3030. Gds Diagnostics has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 8, 1993
- Date Received
- March 12, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Colorimetry, Acetaminophen
- Device Class
- Class II
- Regulation Number
- 862.3030
- Review Panel
- TX
- Submission Type