510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K905402Substantially Equivalent

Antigenz Chlamydia

Northumbria Biologicals, Ltd., Cramlington, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K905402 is the FDA 510(k) clearance record for ANTIGENZ CHLAMYDIA, a class II device, cleared for Northumbria Biologicals , Ltd. on under FDA product code GZB (Stimulator, Spinal-Cord, Implanted (Pain Relief)). FDA records list one 510(k) clearance for Northumbria Biologicals , Ltd. As of , FDA records show no recalls naming K905402.

Clearance record

Decision date
Received
(98 days to decision)
Product code
GZB Stimulator, Spinal-Cord, Implanted (Pain Relief)
Regulation
21 CFR 882.5880
Device class
Class II
Review panel
Neurology
Applicant
Northumbria Biologicals , Ltd. Nelson Industrial Estate, Cramlington, GB
Third party review
No

Clearances, product code GZB

Trailing 12 months

FDA records hold no clearances under product code GZB in the trailing twelve months.

FDA records show no clearances under product code GZB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GZB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260