510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K981634Substantially Equivalent

Biocircuits Ios Prostate Specific Antigen (Psa) Test Cartridges, Biocircuits Ios Psa Controls

Biocircuits Corp., Sunnyvale CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K981634 is the FDA 510(k) clearance record for BIOCIRCUITS IOS PROSTATE SPECIFIC ANTIGEN (PSA) TEST CARTRIDGES, BIOCIRCUITS IOS PSA CONTROLS, a class II device, cleared for Biocircuits Corp. on under FDA product code LTJ (Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers). FDA records list 8 510(k) clearances for Biocircuits Corp., from to . As of , FDA records show no recalls naming K981634.

Clearance record

Decision date
Received
(158 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
Biocircuits Corp. 1324 Chesapeake Terr., Sunnyvale 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