510(k) K900828

PERKIN-ELMER AA 3100 ATOMIC ABSORPTION SPECTRO. by The Perkin-Elmer Corp. — Product Code JXR

K900828 is an FDA 510(k) premarket notification submitted by The Perkin-Elmer Corp. for the device "PERKIN-ELMER AA 3100 ATOMIC ABSORPTION SPECTRO.". The FDA issued a decision of Substantially Equivalent on April 9, 1990. The device falls under product code JXR (Atomic Absorption Spectrophotometer, General Use), a Class I device regulated under 21 CFR 862.2850. The Perkin-Elmer Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 9, 1990
Date Received
February 21, 1990
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