510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K901230Substantially Equivalent

Reaads Anti-Sm Test Kit

Biosearch Medical Products, Inc., Arlington VA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K901230 is the FDA 510(k) clearance record for REAADS ANTI-SM TEST KIT, a class II device, cleared for Biosearch Medical Products, Inc. on under FDA product code LLL (Extractable Antinuclear Antibody, Antigen And Control). FDA records list 70 510(k) clearances for Biosearch Medical Products, Inc., from to . As of , FDA records show no recalls naming K901230.

Clearance record

Decision date
Received
(9 days to decision)
Product code
LLL Extractable Antinuclear Antibody, Antigen And Control
Regulation
21 CFR 866.5100
Device class
Class II
Review panel
Immunology
Applicant
Biosearch Medical Products, Inc. Suite 1203 Crystal Plz. Bldg1, Arlington VA
Third party review
No

Clearances, product code LLL

Trailing 12 months
2 clearances under product code LLL in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LLL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20261
September 20260
October 20260