510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K936060Substantially Equivalent

Atomspec Gf Blood Lead Workstation

Thermo Jarrell Ash Corp.Div.Thermo Inst., Franklin MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K936060 is the FDA 510(k) clearance record for ATOMSPEC GF BLOOD LEAD WORKSTATION, a class II device, cleared for Thermo Jarrell Ash Corp.Div.Thermo Inst. on under FDA product code DOF (Lead, Atomic Absorption). FDA records list one 510(k) clearance for Thermo Jarrell Ash Corp.Div.Thermo Inst. As of , FDA records show no recalls naming K936060.

Clearance record

Decision date
Received
(260 days to decision)
Product code
DOF Lead, Atomic Absorption
Regulation
21 CFR 862.3550
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Thermo Jarrell Ash Corp.Div.Thermo Inst. 8e Forge Pkwy., Franklin MA
510(k) summary
Summary
Third party review
No

Clearances, product code DOF

Trailing 12 months

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

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