510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K881379Substantially Equivalent

Wesblot Rnp-Sm Test

American Bionetics, Inc., Hayward CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K881379 is the FDA 510(k) clearance record for WESBLOT RNP-SM TEST, a class II device, cleared for American Bionetics, Inc. on under FDA product code LKP (Anti-Sm Antibody, Antigen And Control). FDA records list 3 510(k) clearances for American Bionetics, Inc., from to . As of , FDA records show no recalls naming K881379.

Clearance record

Decision date
Received
(45 days to decision)
Product code
LKP Anti-Sm Antibody, Antigen And Control
Regulation
21 CFR 866.5100
Device class
Class II
Review panel
Immunology
Applicant
American Bionetics, Inc. 21377 Cabot Blvd., Hayward CA
Third party review
No

Clearances, product code LKP

Trailing 12 months

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

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