510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K974189Substantially Equivalent

Elecsys Psa (on Elecsys 1010)

Boehringer Mannheim Corp., Pleasanton CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K974189 is the FDA 510(k) clearance record for ELECSYS PSA (ON ELECSYS 1010), a class II device, cleared for Boehringer Mannheim Corp. on under FDA product code LTJ (Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers). FDA records list 340 510(k) clearances for Boehringer Mannheim Corp., from to . As of , FDA records show no recalls naming K974189.

Clearance record

Decision date
Received
(60 days to decision)
Product code
LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
Regulation
21 CFR 866.6010
Device class
Class II
Review panel
Immunology
Applicant
Boehringer Mannheim Corp. 4300 Hacienda Dr., Pleasanton CA
510(k) summary
Summary
Third party review
No

Clearances, product code LTJ

Trailing 12 months
1 clearance under product code LTJ in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LTJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260