510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K974851Substantially Equivalent

San Diego Biotech Hcg Pregnancy Urine Test

San Diego Biotech, San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K974851 is the FDA 510(k) clearance record for SAN DIEGO BIOTECH HCG PREGNANCY URINE TEST, a class II device, cleared for San Diego Biotech on under FDA product code JHI (Visual, Pregnancy Hcg, Prescription Use). FDA records list 2 510(k) clearances for San Diego Biotech, from to . As of , FDA records show no recalls naming K974851.

Clearance record

Decision date
Received
(24 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
San Diego Biotech 7919 Silverton Ave., #409/410, San Diego CA
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