510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K133002Substantially Equivalent

i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT Total beta-hCG Calibration Verification Materials

Abbott Medical, Princton NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K133002 is the FDA 510(k) clearance record for i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT Total beta-hCG Calibration Verification Materials, a class II device, cleared for Abbott Point of Care, Inc. on under FDA product code DHA (System, Test, Human Chorionic Gonadotropin). FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show no recalls naming K133002.

Clearance record

Decision date
Received
(569 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
Abbott Point of Care, Inc. 400 College Rd. E., Princton NJ
510(k) summary
Summary PDF
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