510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K053533Substantially Equivalent

Immulite/immulite 1000 Turbo Intact Pth

Siemens Healthcare Diagnostics Inc., Los Angeles CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K053533 is the FDA 510(k) clearance record for IMMULITE/IMMULITE 1000 TURBO INTACT PTH, a class II device, cleared for Diagnostic Products Corporation on under FDA product code CEW (Radioimmunoassay, Parathyroid Hormone). FDA records list 1,204 510(k) clearances for Siemens Healthcare Diagnostics Inc., from to . As of , FDA records show no recalls naming K053533.

Clearance record

Decision date
Received
(46 days to decision)
Product code
CEW Radioimmunoassay, Parathyroid Hormone
Regulation
21 CFR 862.1545
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Diagnostic Products Corporation 5210 Pacific Concourse Dr., Los Angeles CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code CEW

Trailing 12 months

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

FDA records show no clearances under product code CEW in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code CEW, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260