Diagnostic Products Corp. - FDA 510(k) Cleared Devices
Recent clearances: IMMULITE 2000, IMMULITE 2500 VANCOMYCIN, IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I, IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER
321
Total
321
Cleared
0
Denied
FDA 510(k) Regulatory Record - Diagnostic Products Corp. Microbiology ✕
23 devices
Cleared
Jan 10, 2002
IMMULITE TOXOPLASMA IGM, MODEL LKTM1 AND LKTM2, IMMULITE 2000 TOXOPLASMA IGM,...
Microbiology
192d
Cleared
Jan 10, 2002
IMMULITE RUBELLA IGM,LKRM1, LKRM2, IMMULITE 2000 RUBELLA IGM, MODEL L2KRM2,...
Microbiology
192d
Cleared
Apr 18, 2001
MODIFICATION TO IMMULITE HERPES I & II IGG, MODEL L2KHS2 & L2KHS6
Microbiology
30d
Cleared
Jun 01, 2000
IMMULITE H. PYLORI IGG AND IMMULITE 2000 H. PYLORI IGG
Microbiology
111d
Cleared
Dec 16, 1999
IMMULITE 2000 CMV IGG, MODEL L2KCV2, L2KCV6
Microbiology
24d
Cleared
Mar 18, 1999
PATHODX RESPIRATORY VIRUS PANEL MODEL PKRP1
Microbiology
176d
Cleared
Dec 11, 1998
IMMULITE RUBELLA QUANTITATIVE IGG, CATALOG # LKRBQ1 (100 TESTS), LKRBQ5 (500...
Microbiology
179d
Cleared
Apr 24, 1997
IMMULITE TOXOPLASMA QUANTITATIVE IGG
Microbiology
269d
Cleared
Apr 02, 1997
IMMULITE RUBELLA IGG
Microbiology
204d
Cleared
Jun 21, 1996
IMMULITE HERPES I AND II IGG
Microbiology
494d
Cleared
Jun 17, 1996
IMMULITE CMV IGG
Microbiology
490d
Cleared
Feb 23, 1996
IMMULITE TOXOPLASMA GONDII IGG
Microbiology
375d
Cleared
Dec 19, 1994
PATHODX RESPIRATORY SYNCYTIAL VIRUS (RSV)
Microbiology
161d
Cleared
Mar 25, 1994
PATHODX CYTOMEGALOVIRUS
Microbiology
169d
Cleared
Dec 13, 1990
PATHODX HERPES TYPING
Microbiology
93d
Cleared
Jun 01, 1990
PATHODX PYR KIT
Microbiology
28d
Cleared
Apr 16, 1990
PATHODX CHLAMYDIA TRACHOMATIS DIRECT SPECIMEN TEST
Microbiology
51d
Cleared
Feb 01, 1990
PATHODX CHLAMYDIA CULTURE CONFIRMATION PKCC1
Microbiology
121d
Cleared
Aug 17, 1989
COAT-A-COUNT (TM) FSH IRMA
Microbiology
76d
Cleared
Aug 03, 1989
PATHODX(TM) CHLAMYDIA DIRECT SPECIMEN (PDCY1)
Microbiology
65d
Cleared
Jun 17, 1987
PATHO DX LATEX AGGLUTINATION STREP GROUPING KIT
Microbiology
37d
Cleared
May 02, 1985
PATHO DX LATEX AGGLUTINATION STREP B KIT
Microbiology
126d
Cleared
Jul 02, 1984
PATHO DX LATEX AGGLUTINATION STREP A
Microbiology
14d