510(k) K770255

LC-65T DETECTOR AND OVEN by The Perkin-Elmer Corp. — Product Code KZR

K770255 is an FDA 510(k) premarket notification submitted by The Perkin-Elmer Corp. for the device "LC-65T DETECTOR AND OVEN". The FDA issued a decision of Substantially Equivalent on February 25, 1977. The device falls under product code KZR (Chromatography (Liquid, Gel), Clinical Use), a Class I device regulated under 21 CFR 862.2260. The Perkin-Elmer Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 25, 1977
Date Received
February 10, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chromatography (Liquid, Gel), Clinical Use
Device Class
Class I
Regulation Number
862.2260
Review Panel
TX
Submission Type