Tinaquant Myoglobin Assay

by Boehringer Mannheim Corp. 510(k)

Active United States

510(k) K972513

Regulatory status

as of 28 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK972513	Date28 Jul 1997Cleared	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Withdrawn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 22 Oct 2026.

Specification

510(k)

510(k) Number: K972513
FDA Product Code: DDR

Device Class: Class II
Regulation: 21 CFR Part 866.5680
Advisory Committee: Immunology
FDA Decision: SESE Substantially Equivalent

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