510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K790986Substantially Equivalent

RF Controls

Wampole Laboratories, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K790986 is the FDA 510(k) clearance record for RF CONTROLS, a class I device, cleared for Wampole Laboratories on under FDA product code DMR (Solution, M-Nitrophenol, Specific Reagent For Cholinesterase). FDA records list 12 510(k) clearances for Wampole Laboratories, from to . As of , FDA records show no recalls naming K790986.

Clearance record

Decision date
Received
(34 days to decision)
Product code
DMR Solution, M-Nitrophenol, Specific Reagent For Cholinesterase
Regulation
21 CFR 862.3240
Device class
Class I
Review panel
Clinical Toxicology
Applicant
Wampole Laboratories 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code DMR

Trailing 12 months

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

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