Clinical Sciences, Inc.
Mchenry, IL, US
Clinical Sciences, Inc. appears in FDA device records in Mchenry, IL. FDA records list 30 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 30
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 30 510(k) clearances for Clinical Sciences, Inc. between 1977 and 1990. The busiest year on record is 1979, with 5. The most recent is 1990, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1977 | 1 |
| 1979 | 5 |
| 1980 | 4 |
| 1982 | 2 |
| 1983 | 2 |
| 1984 | 2 |
| 1985 | 1 |
| 1986 | 5 |
| 1988 | 2 |
| 1989 | 5 |
| 1990 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K900688 | VARICELLA ZOSTER IGG CLIN-ELISA TEST KIT | LFY | Substantially Equivalent | |
| K883871 | EPSTEIN-BARR VIRAL CAPSID ANTIGEN IGM #5590 | LSE | Substantially Equivalent | |
| K883870 | EPSTEIN-BARR VIRAL CAPSID ANTIGEN IGG #4590 | LSE | Substantially Equivalent | |
| K891990 | RUBEOLA IGG CLIN-ELISA TEST SYSTEM, CAT. #4600 | LJB | Substantially Equivalent | |
| K883601 | EPSTEIN-BARR VIRUS (EBNA-1) IGM CATA. #5550 | LLM | Substantially Equivalent | |
| K883600 | EPSTEIN-BARR VIRUS (EBNA-1) IGG CATA. #4550 | LLM | Substantially Equivalent | |
| K874594 | TOXOPLASMA IGM CLIN-ELISA(TM) CAT # 5560 | LGD | Substantially Equivalent | |
| K872942 | IGM CMV CLIN-ELISA(TM) TEST SYSTEM NUMBER: 5530 | LKQ | Substantially Equivalent | |
| K860145 | RUBELLA ELISA TEST SYSTEM CATALOG NUMBER: 4540 | LFX | Substantially Equivalent | |
| K860773 | TOXOPLASMA IGG CLIN-ELISA TEST KIT CAT. NO. 4560 | LGD | Substantially Equivalent | |
| K854666 | CYTOMEGALOVIRUS (CMV) ELISA TEST SYS. CAT. NO:4530 | GQI | Substantially Equivalent | |
| K852782 | HSVI - IGG ELISA-KIT | GQO | Substantially Equivalent | |
| K852781 | HSV2 - IGG ELISA-KIT | GQO | Substantially Equivalent | |
| K850158 | CHLAMYDIA FLUORO-KIT 1680 | LJP | Substantially Equivalent | |
| K842541 | RAPID PLASMA REAGIN CARD TEST | GMQ | Substantially Equivalent | |
| K833089 | CYTOMEGALOVIRUS ANTIBODY FLUORO-KIT II | GQH | Substantially Equivalent | |
| K832675 | ANA MICROZYME TEST SYS #1610 | DAA | Substantially Equivalent | |
| K830623 | INDIRECT FLUORO-KIT HSV | GQL | Substantially Equivalent | |
| K822911 | ANAZYME ANA PEROXIDASE TEST SYSTEM | DAA | Substantially Equivalent | |
| K822397 | ANA HEP-2 FLUORO-KIT | DHN | Substantially Equivalent | |
| K801876 | STREP B POLYVALENT FLUORO-KIT | GTX | Substantially Equivalent | |
| K800328 | NEISSERIA GONORRHOEAE FLUORO-KIT | GTH | Substantially Equivalent | |
| K800229 | IMMUNOP. ANTIMITOCHONDRIAL ANTIBODY KIT | DBM | Substantially Equivalent | |
| K800228 | IMMUNOP. ANTISMOOTH MUSCLE ANTIBODY KIT | DBE | Substantially Equivalent | |
| K791749 | INDIRECT IMMUNO ENZYME,ANTIGEN,CONTROL | DAA | Substantially Equivalent | |
| K791827 | LDH CLINI GEL KIT | CFE | Substantially Equivalent | |
| K791826 | CPK CLINI GEL KIT | JHT | Substantially Equivalent | |
| K791447 | MARTIN LEWIS AGAR CSI 3169 | JTY | Substantially Equivalent | |
| K791446 | MARTIN LEWIS JEMBEC CSI 8872 | JTY | Substantially Equivalent | |
| K770057 | NDNA IMMUNOPATH FLUORO-KIT | DHN | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- LKQAntibody Igm,If, Cytomegalovirus Virus
- GQHAntigen, Cf (Including Cf Control), Cytomegalovirus
- GMQAntigens, Nontreponemal, All
- DBMAntimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
- DHNAntinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
- GQOAntisera, Cf, Herpesvirus Hominis 1,2
- GTXAntisera, Fluorescent, All Groups, Streptococcus Spp.
- GQLAntisera, Fluorescent, Herpesvirus Hominis 1,2
- GQIAntiserum, Cf, Cytomegalovirus
- GTHAntiserum, Fluorescent (Direct Test), All Groups, N. Gonorrhoeae
- LJPAntiserum, Fluorescent, Chlamydia Trachomatis
- DBEAntismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Control
- JHTChromatographic Separation, Cpk Isoenzymes
- JTYCulture Media, For Isolation Of Pathogenic Neisseria
- CFEElectrophoretic, Lactate Dehydrogenase Isoenzymes
- LFXEnzyme Linked Immunoabsorbent Assay, Rubella
- LJBEnzyme Linked Immunoabsorbent Assay, Rubeola Igg
- LGDEnzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
- LFYEnzyme Linked Immunoabsorbent Assay, Varicella-Zoster
- LSEEpstein-Barr Virus, Other
- DAAIgg, Peroxidase, Antigen, Antiserum, Control
- LLMTest, Antigen, Nuclear, Epstein-Barr Virus
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain