510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K040575Substantially Equivalent

Pharmatech Menopause Check, Models 9111 and 9112

Phamatech Inc., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K040575 is the FDA 510(k) clearance record for PHARMATECH MENOPAUSE CHECK, MODELS 9111 AND 9112, a class I device, cleared for Phamatech, Inc. on under FDA product code CGJ (Radioimmunoassay, Follicle-Stimulating Hormone). FDA records list 62 510(k) clearances for Phamatech, Inc., from to . As of , FDA records show no recalls naming K040575.

Clearance record

Decision date
Received
(77 days to decision)
Product code
CGJ Radioimmunoassay, Follicle-Stimulating Hormone
Regulation
21 CFR 862.1300
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Phamatech, Inc. 10151 Barnes Canyon Rd., San Diego CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code CGJ

Trailing 12 months

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

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