510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K864645Substantially Equivalent

Adenolex (R) Latex Agglutination Test

Orion Diagnostica, Inc., Somerset NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864645 is the FDA 510(k) clearance record for ADENOLEX (R) LATEX AGGLUTINATION TEST, a class I device, cleared for Orion Diagnostica, Inc. on under FDA product code GOD (Antigens, Cf (Including Cf Control), Adenovirus 1-33). FDA records list 32 510(k) clearances for Orion Diagnostica, Inc., from to . As of , FDA records show no recalls naming K864645.

Clearance record

Decision date
Received
(191 days to decision)
Product code
GOD Antigens, Cf (Including Cf Control), Adenovirus 1-33
Regulation
21 CFR 866.3020
Device class
Class I
Review panel
Microbiology
Applicant
Orion Diagnostica, Inc. 71 Veronica Ave., Somerset NJ
Third party review
No

Clearances, product code GOD

Trailing 12 months

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

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