Hepatitis Negative Control

by Pyramid Biological Corp. 510(k)

Active United States

510(k) K962399

Regulatory status

as of 27 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK962399	Date2 Aug 1996Cleared	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Withdrawn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 10 Oct 2026.

Specification

510(k)

510(k) Number: K962399
FDA Product Code: MJY

Device Class: Class I
Regulation: 21 CFR Part 862.1660
Advisory Committee: Clinical Chemistry
FDA Decision: SESE Substantially Equivalent

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