510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K983762Substantially Equivalent

Nuclisens Cmv Pp67

bioMerieux, Inc., Durham NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K983762 is the FDA 510(k) clearance record for NUCLISENS CMV PP67, a class II device, cleared for Organon Teknika Corp. on under FDA product code LIN (Antisera, Conjugated Fluorescent, Cytomegalovirus). FDA records list 408 510(k) clearances for BIOMERIEUX, INC., from to . As of , FDA records show no recalls naming K983762.

Clearance record

Decision date
Received
(324 days to decision)
Product code
LIN Antisera, Conjugated Fluorescent, Cytomegalovirus
Regulation
21 CFR 866.3175
Device class
Class II
Review panel
Microbiology
Applicant
Organon Teknika Corp. 100 Akzo Ave., Durham NC
510(k) summary
Summary
Third party review
No

Clearances, product code LIN

Trailing 12 months

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

FDA records show no clearances under product code LIN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LIN, 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