510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K031048Substantially Equivalent

Carestart Hcg Combo One-Step Pregnancy Test and Carestart Plus Hcg Combo One-Step Pregnancy Test

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

K031048 is the FDA 510(k) clearance record for CARESTART HCG COMBO ONE-STEP PREGNANCY TEST AND CARESTART PLUS HCG COMBO ONE-STEP PREGNANCY TEST, a class II device, cleared for Access Bio Incorporate on under FDA product code JHI (Visual, Pregnancy Hcg, Prescription Use). FDA records list 4 510(k) clearances for Access Bio Incorporate, from to . As of , FDA records show no recalls naming K031048.

Clearance record

Decision date
Received
(75 days to decision)
Product code
JHI Visual, Pregnancy Hcg, Prescription Use
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 JHI

Trailing 12 months
1 clearance under product code JHI in the twelve months to October 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JHI, 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 20261
October 20260