510(k) K780342

SPECTROPHOTOMETERS by The Perkin-Elmer Corp. — Product Code JXR

K780342 is an FDA 510(k) premarket notification submitted by The Perkin-Elmer Corp. for the device "SPECTROPHOTOMETERS". The FDA issued a decision of Substantially Equivalent on April 10, 1978. 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 10, 1978
Date Received
March 2, 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