510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K901537Substantially Equivalent

Modified Opus Phenobarbital Test System

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

K901537 is the FDA 510(k) clearance record for MODIFIED OPUS PHENOBARBITAL TEST SYSTEM, a class II device, cleared for Pb Diagnostic Systems, Inc. on under FDA product code LET (Fluorescent Immunoassay, Phenobarbital). FDA records list 35 510(k) clearances for Pb Diagnostic Systems, Inc., from to . As of , FDA records show no recalls naming K901537.

Clearance record

Decision date
Received
(71 days to decision)
Product code
LET Fluorescent Immunoassay, Phenobarbital
Regulation
21 CFR 862.3660
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Pb Diagnostic Systems, Inc. 151 University Ave., Westwood MA
Third party review
No

Clearances, product code LET

Trailing 12 months

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

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