Syphilis Igm Human Serum Controls

by Pyramid Biological Corp. 510(k)

Active United States

510(k) K961317

Regulatory status

as of 27 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK961317	Date24 Jun 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Withdrawn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 22 Oct 2026.

Specification

510(k)

510(k) Number: K961317
FDA Product Code: LIP

Device Class: Class II
Regulation: 21 CFR Part 866.3830
Advisory Committee: Microbiology
FDA Decision: SESE Substantially Equivalent

Other devices from Pyramid Biological Corp.

H.pylori Controls

Class I
B-Hcg Human Serum Controls

Class I
Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus

Class II
Cmv Igg Human Serum Controls

Class II
Hepatitis Negative Control

Class I
Refractometric, Total Protein

Class I

See all devices from Pyramid Biological Corp. →