510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K970695Substantially Equivalent

Acs:180 Br (Automated Chemiluminescence System for the Quantitation of Cancer Antigen 27.29)

Chiron Diagnostics Corp., Alameda CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K970695 is the FDA 510(k) clearance record for ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER ANTIGEN 27.29), a class II device, cleared for Chiron Diagnostics Corp. on under FDA product code MOI (System, Test, Immunological, Antigen, Tumor). FDA records list 20 510(k) clearances for Chiron Diagnostics Corp., from to . As of , FDA records show no recalls naming K970695.

Clearance record

Decision date
Received
(164 days to decision)
Product code
MOI System, Test, Immunological, Antigen, Tumor
Regulation
21 CFR 866.6010
Device class
Class II
Review panel
Immunology
Applicant
Chiron Diagnostics Corp. 1401 Harbor Bay Pkwy., Alameda CA
510(k) summary
Summary
Third party review
No

Clearances, product code MOI

Trailing 12 months

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

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