Medical Device Manufacturer · US , Mchenry , IL

Clinical Sciences, Inc. - FDA 510(k) Cleared Devices

30 submissions · 30 cleared · Since 1977
30
Total
30
Cleared
0
Denied

FDA 510(k) Regulatory Record - Clinical Sciences, Inc. Microbiology

21 devices
1-21 of 21
Cleared May 15, 1990
VARICELLA ZOSTER IGG CLIN-ELISA TEST KIT
K900688 · LFY
Microbiology · 91d
Cleared Jul 14, 1989
EPSTEIN-BARR VIRAL CAPSID ANTIGEN IGG #4590
K883870 · LSE
Microbiology · 304d
Cleared Jul 14, 1989
EPSTEIN-BARR VIRAL CAPSID ANTIGEN IGM #5590
K883871 · LSE
Microbiology · 304d
Cleared Jun 15, 1989
RUBEOLA IGG CLIN-ELISA TEST SYSTEM, CAT. #4600
K891990 · LJB
Microbiology · 79d
Cleared May 11, 1989
EPSTEIN-BARR VIRUS (EBNA-1) IGG CATA. #4550
K883600 · LLM
Microbiology · 261d
Cleared May 11, 1989
EPSTEIN-BARR VIRUS (EBNA-1) IGM CATA. #5550
K883601 · LLM
Microbiology · 261d
Cleared Mar 07, 1988
TOXOPLASMA IGM CLIN-ELISA(TM) CAT # 5560
K874594 · LGD
Microbiology · 119d
Cleared Jan 11, 1988
IGM CMV CLIN-ELISA(TM) TEST SYSTEM NUMBER: 5530
K872942 · LKQ
Microbiology · 168d
Cleared Jul 14, 1986
RUBELLA ELISA TEST SYSTEM CATALOG NUMBER: 4540
K860145 · LFX
Microbiology · 180d
Cleared May 23, 1986
TOXOPLASMA IGG CLIN-ELISA TEST KIT CAT. NO. 4560
K860773 · LGD
Microbiology · 81d
Cleared Feb 05, 1986
CYTOMEGALOVIRUS (CMV) ELISA TEST SYS. CAT. NO:4530
K854666 · GQI
Microbiology · 76d
Cleared Jan 21, 1986
HSV2 - IGG ELISA-KIT
K852781 · GQO
Microbiology · 204d
Cleared Jan 21, 1986
HSVI - IGG ELISA-KIT
K852782 · GQO
Microbiology · 204d
Cleared Mar 21, 1985
CHLAMYDIA FLUORO-KIT 1680
K850158 · LJP
Microbiology · 65d
Cleared Jul 26, 1984
RAPID PLASMA REAGIN CARD TEST
K842541 · GMQ
Microbiology · 24d
Cleared May 02, 1984
CYTOMEGALOVIRUS ANTIBODY FLUORO-KIT II
K833089 · GQH
Microbiology · 233d
Cleared Jul 07, 1983
INDIRECT FLUORO-KIT HSV
K830623 · GQL
Microbiology · 129d
Cleared Sep 16, 1980
STREP B POLYVALENT FLUORO-KIT
K801876 · GTX
Microbiology · 42d
Cleared Mar 03, 1980
NEISSERIA GONORRHOEAE FLUORO-KIT
K800328 · GTH
Microbiology · 20d
Cleared Sep 17, 1979
MARTIN LEWIS JEMBEC CSI 8872
K791446 · JTY
Microbiology · 48d
Cleared Sep 17, 1979
MARTIN LEWIS AGAR CSI 3169
K791447 · JTY
Microbiology · 48d
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