510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K863488Substantially Equivalent

Enzygnost Anti-Cmv Igg Test

Behring Diagnostics, Inc., La Jolla CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K863488 is the FDA 510(k) clearance record for ENZYGNOST ANTI-CMV IGG TEST, a class II device, cleared for Behring Diagnostics, Inc. on under FDA product code GQI (Antiserum, Cf, Cytomegalovirus). FDA records list 145 510(k) clearances for Behring Diagnostics, Inc., from to . As of , FDA records show no recalls naming K863488.

Clearance record

Decision date
Received
(314 days to decision)
Product code
GQI Antiserum, Cf, Cytomegalovirus
Regulation
21 CFR 866.3175
Device class
Class II
Review panel
Microbiology
Applicant
Behring Diagnostics, Inc. 10933 No Torrey Pines Rd., La Jolla CA
Third party review
No

Clearances, product code GQI

Trailing 12 months

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

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