510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K042676Substantially Equivalent

Nichols Advantage Hyperglycosylated Human Chorionic Gonadotropin (H-Hcg) Assay

Nichols Institute Diagnostics, San Clemente CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K042676 is the FDA 510(k) clearance record for NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTROPIN (H-HCG) ASSAY, a class II device, cleared for Nichols Institute Diagnostics on under FDA product code DHA (System, Test, Human Chorionic Gonadotropin). FDA records list 68 510(k) clearances for Nichols Institute Diagnostics, from to . As of , FDA records show one recall naming K042676.

Clearance record

Decision date
Received
(79 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
Nichols Institute Diagnostics 1311 Calle Batido, San Clemente CA
510(k) summary
Summary PDF
Third party review
Yes

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