510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K884784Substantially Equivalent

Virgo(r) Microwell Alt Assay

Electro-Nucleonics, Inc., Columbia MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K884784 is the FDA 510(k) clearance record for VIRGO(R) MICROWELL ALT ASSAY, a class I device, cleared for Electro-Nucleonics, Inc. on under FDA product code CKD (Hydrazone Colorimetry, Alt/Sgpt). FDA records list 9 510(k) clearances for Electro-Nucleonics, Inc., from to . As of , FDA records show no recalls naming K884784.

Clearance record

Decision date
Received
(44 days to decision)
Product code
CKD Hydrazone Colorimetry, Alt/Sgpt
Regulation
21 CFR 862.1030
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Electro-Nucleonics, Inc. 8310 Guilford Rd., Columbia MD
Third party review
No

Clearances, product code CKD

Trailing 12 months

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

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