510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K915650Substantially Equivalent

Human Igg Subclass Rid Kit

Janssen Biochimica, Piscataway NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K915650 is the FDA 510(k) clearance record for HUMAN IGG SUBCLASS RID KIT, a class II device, cleared for Janssen Biochimica on under FDA product code CGM (Method, Immunodiffusion, Immunoglobulins (G, A, M)). FDA records list one 510(k) clearance for Janssen Biochimica. As of , FDA records show no recalls naming K915650.

Clearance record

Decision date
Received
(99 days to decision)
Product code
CGM Method, Immunodiffusion, Immunoglobulins (G, A, M)
Regulation
21 CFR 866.5510
Device class
Class II
Review panel
Immunology
Applicant
Janssen Biochimica 40 Kingsbridge Rd., Piscataway NJ
510(k) summary
Statement
Third party review
No

Clearances, product code CGM

Trailing 12 months

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

FDA records show no clearances under product code CGM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code CGM, 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