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
K964155Substantially Equivalent

Contrast Hcg Urine/serum Test and Rapid Hcg Urine/serum Test

Sekisui Diagnostics, LLC, San Carlos CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K964155 is the FDA 510(k) clearance record for CONTRAST HCG URINE/SERUM TEST AND RAPID HCG URINE/SERUM TEST, a class II device, cleared for Genzyme Diagnostics on under FDA product code JHI (Visual, Pregnancy Hcg, Prescription Use). FDA records list 21 510(k) clearances for Sekisui Diagnostics, LLC, from to . As of , FDA records show no recalls naming K964155.

Clearance record

Decision date
Received
(40 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
Genzyme Diagnostics 1531 Industrial Rd., San Carlos CA
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 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