510(k) K791431
K791431 is an FDA 510(k) premarket notification submitted by Technicon Instruments Corp. for the device "TECHNICON FAST-LC SYS. FOR THEOPHYLLINE". The FDA issued a decision of Substantially Equivalent on October 11, 1979. The device falls under product code DPA (Apparatus, General Use, Thin Layer Chromatography), a Class I device regulated under 21 CFR 862.2270. Technicon Instruments Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 11, 1979
- Date Received
- July 26, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Apparatus, General Use, Thin Layer Chromatography
- Device Class
- Class I
- Regulation Number
- 862.2270
- Review Panel
- TX
- Submission Type