510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K911396Substantially Equivalent

Sr1 Estradiol Enzyme Immunoassay

Serono-Baker Diagnostics, Inc., Allentown PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K911396 is the FDA 510(k) clearance record for SR1 ESTRADIOL ENZYME IMMUNOASSAY, a class I device, cleared for Serono-Baker Diagnostics, Inc. on under FDA product code CHP (Radioimmunoassay, Estradiol). FDA records list 23 510(k) clearances for Serono-Baker Diagnostics, Inc., from to . As of , FDA records show no recalls naming K911396.

Clearance record

Decision date
Received
(60 days to decision)
Product code
CHP Radioimmunoassay, Estradiol
Regulation
21 CFR 862.1260
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Serono-Baker Diagnostics, Inc. 100 Cascade Dr., Allentown PA
Third party review
No

Clearances, product code CHP

Trailing 12 months

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

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