510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K002148Substantially Equivalent

Elecsys Hcg Test System

Roche Diagnostics GmbH, Indianapolis IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K002148 is the FDA 510(k) clearance record for ELECSYS HCG TEST SYSTEM, a class II device, cleared for Roche Diagnostics Corp. on under FDA product code DHA (System, Test, Human Chorionic Gonadotropin). FDA records list 465 510(k) clearances for Roche Diagnostics Corp., from to . As of , FDA records show no recalls naming K002148.

Clearance record

Decision date
Received
(36 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
Roche Diagnostics Corp. 9115 Hague Rd., P.O. Box 50457, Indianapolis IN
510(k) summary
Summary
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 November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DHA, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260