510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K950570Substantially Equivalent

Stratus Progesterone Fluorometric Enzyme Immunoassay

Baxter Diagnostics, Inc., Miami FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K950570 is the FDA 510(k) clearance record for STRATUS PROGESTERONE FLUOROMETRIC ENZYME IMMUNOASSAY, a class I device, cleared for Baxter Diagnostics, Inc. on under FDA product code JLS (Radioimmunoassay, Progesterone). FDA records list 72 510(k) clearances for Baxter Diagnostics, Inc., from to . As of , FDA records show no recalls naming K950570.

Clearance record

Decision date
Received
(67 days to decision)
Product code
JLS Radioimmunoassay, Progesterone
Regulation
21 CFR 862.1620
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Baxter Diagnostics, Inc. P.O.Box 520672, Miami FL
510(k) summary
Summary
Third party review
No

Clearances, product code JLS

Trailing 12 months

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

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