Agglutinating Serum W135

by Burroughs Wellcome Co. 510(k)

Active United States

510(k) K771562

Regulatory status

as of 27 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK771562	Date25 Aug 1977Cleared	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Withdrawn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: K771562
FDA Product Code: GTJ

Device Class: Class II
Regulation: 21 CFR Part 866.3390
Advisory Committee: Microbiology
FDA Decision: SESE Substantially Equivalent

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