510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K070820Substantially Equivalent

Architect Tacrolimus: Model 1L77

Fujirebio Diagnostics, Inc., Malvern PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K070820 is the FDA 510(k) clearance record for ARCHITECT TACROLIMUS: MODEL 1L77, a class II device, cleared for Fujirebio Diagnostics,Inc. on under FDA product code MLM (Enzyme Immunoassay, Tracrolimus). FDA records list 45 510(k) clearances for Fujirebio Diagnostics,Inc., from to . As of , FDA records show one recall naming K070820.

Clearance record

Decision date
Received
(128 days to decision)
Product code
MLM Enzyme Immunoassay, Tracrolimus
Regulation
21 CFR 862.1678
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Fujirebio Diagnostics,Inc. 201 Great Valley Pkwy., Malvern PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MLM

Trailing 12 months

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

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