Hcg Controls

by International Newtech Development, Inc. 510(k)

Active United States

510(k) K970176

Regulatory status

as of 28 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK970176	Date6 Feb 1997Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
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: K970176
FDA Product Code: JJX

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

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