510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K031052Substantially Equivalent

Carestart Hcg One-Step Pregnancy Test

Access Bio Incorporate, North Brunswick NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K031052 is the FDA 510(k) clearance record for CARESTART HCG ONE-STEP PREGNANCY TEST, a class II device, cleared for Access Bio Incorporate on under FDA product code DHA (System, Test, Human Chorionic Gonadotropin). FDA records list 4 510(k) clearances for Access Bio Incorporate, from to . As of , FDA records show no recalls naming K031052.

Clearance record

Decision date
Received
(72 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
Access Bio Incorporate 675 Us Hwy. 1, North Brunswick NJ
510(k) summary
Statement
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