510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K963268Substantially Equivalent

Genesis Rmp

Tecan U.S., Research Triangle Park NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K963268 is the FDA 510(k) clearance record for GENESIS RMP, a class I device, cleared for Tecan U.S., Inc. on under FDA product code JRA (Microtitrator, For Clinical Use). FDA records list 10 510(k) clearances for Tecan U.S., Inc., from to . As of , FDA records show no recalls naming K963268.

Clearance record

Decision date
Received
(210 days to decision)
Product code
JRA Microtitrator, For Clinical Use
Regulation
21 CFR 862.2680
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Tecan U.S., Inc. P.O. Box 13953, Research Triangle Park NC
510(k) summary
Statement
Third party review
No

Clearances, product code JRA

Trailing 12 months

FDA records hold no clearances under product code JRA in the trailing twelve months.

FDA records show no clearances under product code JRA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JRA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260