510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K943691Substantially Equivalent

Imx Folate

Abbott Mfg., Inc., Abbott Park IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K943691 is the FDA 510(k) clearance record for IMX FOLATE, a class II device, cleared for Abbott Mfg., Inc. on under FDA product code CGN (Acid, Folic, Radioimmunoassay). FDA records list 14 510(k) clearances for Abbott Mfg., Inc., from to . As of , FDA records show 5 recalls naming K943691.

Clearance record

Decision date
Received
(237 days to decision)
Product code
CGN Acid, Folic, Radioimmunoassay
Regulation
21 CFR 862.1295
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Abbott Mfg., Inc. 200 Abbott Park Rd., Abbott Park IL
510(k) summary
Summary
Third party review
No

Clearances, product code CGN

Trailing 12 months

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

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