510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K781009Substantially Equivalent

Analyzer, Serum Iron & Total Iron Bindin

Environmental Sciences Assoc., Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K781009 is the FDA 510(k) clearance record for ANALYZER, SERUM IRON & TOTAL IRON BINDIN, a class I device, cleared for Environmental Sciences Assoc., Inc. on under FDA product code JMD (Radioimmunoassay, Total Estrogens, Nonpregnancy). FDA records list 2 510(k) clearances for Environmental Sciences Assoc., Inc., from to . As of , FDA records show no recalls naming K781009.

Clearance record

Decision date
Received
(38 days to decision)
Product code
JMD Radioimmunoassay, Total Estrogens, Nonpregnancy
Regulation
21 CFR 862.1275
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Environmental Sciences Assoc., Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code JMD

Trailing 12 months

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

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