510(k) K780390

SPECTROPHOTOMETER, ABSORPTION, ATOMIC by Varian Assoc., Inc. — Product Code JXR

K780390 is an FDA 510(k) premarket notification submitted by Varian Assoc., Inc. for the device "SPECTROPHOTOMETER, ABSORPTION, ATOMIC". The FDA issued a decision of Substantially Equivalent on March 22, 1978. The device falls under product code JXR (Atomic Absorption Spectrophotometer, General Use), a Class I device regulated under 21 CFR 862.2850. Varian Assoc., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 1978
Date Received
March 10, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Atomic Absorption Spectrophotometer, General Use
Device Class
Class I
Regulation Number
862.2850
Review Panel
TX
Submission Type