510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K892241Substantially Equivalent

Fetal Hemoglobin

Sure-Tech Diagnostic Associates, Inc., St. Louis MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K892241 is the FDA 510(k) clearance record for FETAL HEMOGLOBIN, a class II device, cleared for Sure-Tech Diagnostic Associates, Inc. on under FDA product code GHQ (Stain, Fetal Hemoglobin). FDA records list one 510(k) clearance for Sure-Tech Diagnostic Associates, Inc. As of , FDA records show no recalls naming K892241.

Clearance record

Decision date
Received
(56 days to decision)
Product code
GHQ Stain, Fetal Hemoglobin
Regulation
21 CFR 864.7455
Device class
Class II
Review panel
Hematology
Applicant
Sure-Tech Diagnostic Associates, Inc. 11012 Lin Valle Dr., Suite D, St. Louis MO
Third party review
No

Clearances, product code GHQ

Trailing 12 months

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

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