510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K893953Substantially Equivalent

Absolute(tm)-Hcg Urine Pregnancy Test

Totem Diagnostics, Inc., Vancouver, B.C. V5z 4h5, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K893953 is the FDA 510(k) clearance record for ABSOLUTE(TM)-HCG URINE PREGNANCY TEST, a class II device, cleared for Totem Diagnostics, Inc. on under FDA product code DHA (System, Test, Human Chorionic Gonadotropin). FDA records list one 510(k) clearance for Totem Diagnostics, Inc. As of , FDA records show no recalls naming K893953.

Clearance record

Decision date
Received
(75 days to decision)
Product code
DHA System, Test, Human Chorionic Gonadotropin
Regulation
21 CFR 862.1155
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Totem Diagnostics, Inc. 520 W. 6th Ave., Vancouver, B.C. V5z 4h5, CA
Third party review
No

Clearances, product code DHA

Trailing 12 months

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

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