LTJ · Class II · 21 CFR 866.6010

FDA Product Code LTJ: Prostate-specific Antigen (psa) For Management Of Prostate Cancers

Leading manufacturers include Boehringer Mannheim Corp., Bayer Corp. and Diagnostic Products Corp..

34
Total
34
Cleared
122d
Avg days
1997
Since
34 devices
25–34 of 34
Cleared Apr 21, 1998
IMMULITE 2000 3RD GENERATION PSA
K974842
Diagnostic Products Corp.
Immunology · 118d
Cleared Apr 03, 1998
ADVANTAGE CHEMILUMINESCENCE PROSTATE SPECIFIC ANTIGEN (PSA) IMMUNOASSAY
K980716
Nichols Institute Diagnostics
Immunology · 86d
Cleared Feb 20, 1998
ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229
K974816
Beckman Instruments, Inc.
Immunology · 59d
Cleared Jan 06, 1998
ELECSYS PSA (ON ELECSYS 1010)
K974189
Boehringer Mannheim Corp.
Immunology · 60d
Cleared Oct 31, 1997
IMMULITE THIRD GENERATION PSA (LKUPI,LKUP5)
K972021
Diagnostic Products Corp.
Immunology · 151d
Cleared Sep 18, 1997
PROSTATE SPECIFIC ANTIGEN METHOD
K973101
Dade Chemistry Systems, Inc.
Immunology · 30d
Cleared Aug 22, 1997
IMMULITE 2000 PSA
K972095
Diagnostic Products Corp.
Immunology · 79d
Cleared Jul 25, 1997
ELECSYS PSA ASSAY
K964351
Boehringer Mannheim Corp.
Immunology · 266d
Cleared Jun 24, 1997
OPUS PSA TEST SYSTEM
K964595
Behring Diagnostics, Inc.
Immunology · 218d
Cleared Mar 19, 1997
ENZYMUN-TEST PSA
K965085
Boehringer Mannheim Corp.
Immunology · 90d