510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K191462Substantially Equivalent

Proov Test

MFB Fertility, Inc., Erie CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K191462 is the FDA 510(k) clearance record for Proov Test, a class I device, cleared for Mfb Fertility, Inc. on under FDA product code QKE (Immunoassay, Pregnanediol Glucuronide, Over The Counter). FDA's definition for product code QKE reads: "Over-the-counter detection of pregnanediol glucuronide for the confirmation of ovulation". FDA records list one 510(k) clearance for Mfb Fertility, Inc. As of , FDA records show no recalls naming K191462.

Clearance record

Decision date
Received
(269 days to decision)
Product code
QKE Immunoassay, Pregnanediol Glucuronide, Over The Counter
Regulation
21 CFR 862.1620
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Mfb Fertility, Inc. 999 Sumner Way, Erie CO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QKE

Trailing 12 months

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

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