510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K854207Substantially Equivalent

Ebv(epstein-Barr Virus) Test Kit

Immuno-Diagnostic Products, Inc., North Salt Lake UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K854207 is the FDA 510(k) clearance record for EBV(EPSTEIN-BARR VIRUS) TEST KIT, a class I device, cleared for Immuno-Diagnostic Products, Inc. on under FDA product code GNP (Antiserum, Cf, Epstein-Barr Virus). FDA records list 8 510(k) clearances for Immuno-Diagnostic Products, Inc., from to . As of , FDA records show no recalls naming K854207.

Clearance record

Decision date
Received
(190 days to decision)
Product code
GNP Antiserum, Cf, Epstein-Barr Virus
Regulation
21 CFR 866.3235
Device class
Class I
Review panel
Microbiology
Applicant
Immuno-Diagnostic Products, Inc. P.O. Box 193, North Salt Lake UT
Third party review
No

Clearances, product code GNP

Trailing 12 months

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

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