510(k) K791431

TECHNICON FAST-LC SYS. FOR THEOPHYLLINE by Technicon Instruments Corp. — Product Code DPA

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