510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K980736Substantially Equivalent

Acon Hcg One Step Urine/serum Pregnancy Test

Acon Laboratories, Inc., Bethlehem PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K980736 is the FDA 510(k) clearance record for ACON HCG ONE STEP URINE/SERUM PREGNANCY TEST, a class II device, cleared for Acon Laboratories Co. on under FDA product code JHI (Visual, Pregnancy Hcg, Prescription Use). FDA records list 93 510(k) clearances for Acon Laboratories Co., from to . As of , FDA records show no recalls naming K980736.

Clearance record

Decision date
Received
(50 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
Acon Laboratories Co. 115 Research Dr., Bethlehem PA
510(k) summary
Summary
Third party review
No

Clearances, product code JHI

Trailing 12 months
1 clearance under product code JHI in the twelve months to November 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JHI, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260
November 20260