510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K897193Substantially Equivalent

Opus T4 Test System

Pb Diagnostic Systems, Inc., Westwood MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K897193 is the FDA 510(k) clearance record for OPUS T4 TEST SYSTEM, a class II device, cleared for Pb Diagnostic Systems, Inc. on under FDA product code KLI (Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine). FDA records list 35 510(k) clearances for Pb Diagnostic Systems, Inc., from to . As of , FDA records show no recalls naming K897193.

Clearance record

Decision date
Received
(80 days to decision)
Product code
KLI Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
Regulation
21 CFR 862.1700
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Pb Diagnostic Systems, Inc. 151 University Ave., Westwood MA
Third party review
No

Clearances, product code KLI

Trailing 12 months

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

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