Cholesterol Det. in Serum

by Fisher Scientific Co., LLC 510(k)

Active United States

510(k) K781611

Regulatory status

as of 28 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK781611	Date24 Oct 1978Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 9 Oct 2026.

Specification

510(k)

510(k) Number: K781611
FDA Product Code: CGO

Device Class: Class I
Regulation: 21 CFR Part 862.1175
Advisory Committee: Clinical Chemistry
FDA Decision: SESE Substantially Equivalent

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