510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K971640Substantially Equivalent

Leadcare Blood Lead Testing System

Esa, Inc., Chelmsford MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K971640 is the FDA 510(k) clearance record for LEADCARE BLOOD LEAD TESTING SYSTEM, a class II device, cleared for Esa, Inc. on under FDA product code DOF (Lead, Atomic Absorption). FDA records list 3 510(k) clearances for Esa, Inc., from to . As of , FDA records show 3 recalls naming K971640.

Clearance record

Decision date
Received
(130 days to decision)
Product code
DOF Lead, Atomic Absorption
Regulation
21 CFR 862.3550
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Esa, Inc. 22 Alpha Rd., Chelmsford MA
510(k) summary
Statement
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