Clinical Assays, Inc.
Mchenry, IL, US
Clinical Assays, Inc. appears in FDA device records in Mchenry, IL. FDA records list 27 510(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
- 27
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 27 510(k) clearances for Clinical Assays, Inc. between 1977 and 1983. The busiest year on record is 1977, with 7. The most recent is 1983, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1977 | 7 |
| 1978 | 5 |
| 1979 | 4 |
| 1980 | 1 |
| 1981 | 3 |
| 1982 | 4 |
| 1983 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K832712 | FOLATE RADIOASSAY KIT CA-1562-125 | CGN | Substantially Equivalent | |
| K832711 | VITAMIN B12 FOLATE CA-1515-125 | CDD | Substantially Equivalent | |
| K832710 | VITAMIN B12 RADIOASSAY KIT CA-1534 | CDD | Substantially Equivalent | |
| K823476 | GAMMADAB LH RADIO-KIT #CA-1508 | CEP | Substantially Equivalent | |
| K823313 | IN VITRO GAMMACOAT B-HCG RADIO. TEST | JHI | Substantially Equivalent | |
| K821611 | GAMMADAB [125] FSH RADIOIMMUNAY KIT | CGJ | Substantially Equivalent | |
| K821092 | GAMMADAB[125]EGE RADIOIMMUNOASSAY IT | DGC | Substantially Equivalent | |
| K812227 | GAMMACOAT (125) INSULIN RADIOIMMUNOASSAY | CFP | Substantially Equivalent | |
| K810722 | GASTRIN RADIOIMMUNOASSAY TEST | CGC | Substantially Equivalent | |
| K810967 | IN-VITRO TBG RADIOIMMUNOASSAY TEST | CEE | Substantially Equivalent | |
| K801667 | GAMMA COAT(125 I) RUBELLA ANTIBODY | GOL | Substantially Equivalent | |
| K791497 | PROSTATIC ACID RADIOIMMUNOASSAY TEST | JFH | Substantially Equivalent | |
| K791079 | GAMMADAB (125 1) FOLATE RADIOASSAY KIT | CGN | Substantially Equivalent | |
| K782109 | RIA KIT, GAMMACOAT | CDX | Substantially Equivalent | |
| K781938 | RIA KIT, GAMMADAB ESTRIOL | CGI | Substantially Equivalent | |
| K781235 | IV VITRO GAMMADAB T4 RIA KIT | CDX | Substantially Equivalent | |
| K780934 | IN VITRO TOBRAMYCIN RIA KIT | KLB | Substantially Equivalent | |
| K780854 | IN VITRO NEONATAL T4 | CDX | Substantially Equivalent | |
| K780709 | IN VITRO GENTAMICIN RADIOIMMUNOASSY TEST | Substantially Equivalent | ||
| K772017 | IN VITRO THEOPHYLLINE RIA TEST | KLS | Substantially Equivalent | |
| K772109 | IN VITRO HUMAN TSH RIA TEST | JLW | Substantially Equivalent | |
| K772111 | IN VITRO PHENOBARBITAL RIA TEST | DKP | Substantially Equivalent | |
| K772110 | IN VITRO DIGOXIN RIA TEST | DNL | Substantially Equivalent | |
| K772108 | IN VITRO T3 RIA TEST | CDP | Substantially Equivalent | |
| K771597 | IN VITRO FOLATE RADIOASSAY KIT | CGN | Substantially Equivalent | |
| K770702 | IN VITRO FERRITIN RIA TEST | DBF | Substantially Equivalent | |
| K770480 | IN VITRO T-3 UPTAKE TEST | KHQ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- JFHAcid Phosphatase (Prostatic), Tartrate Inhibited
- CGNAcid, Folic, Radioimmunoassay
- GOLAntigen, Ha (Including Ha Control), Rubella
- KLSEnzyme Immunoassay, Theophylline
- DBFFerritin, Antigen, Antiserum, Control
- DGCIge, Antigen, Antiserum, Control
- KHQRadioassay, Triiodothyronine Uptake
- CDDRadioassay, Vitamin B12
- DNLRadioimmunoassay, Digoxin (125-I), Rabbit Antibody, Second Antibody Sep.
- CGIRadioimmunoassay, Estriol
- CGJRadioimmunoassay, Follicle-Stimulating Hormone
- CGCRadioimmunoassay, Gastrin
- CFPRadioimmunoassay, Immunoreactive Insulin
- CEPRadioimmunoassay, Luteinizing Hormone
- DKPRadioimmunoassay, Phenobarbital
- JLWRadioimmunoassay, Thyroid-Stimulating Hormone
- CEERadioimmunoassay, Thyroxine-Binding Globulin
- KLBRadioimmunoassay, Tobramycin
- CDXRadioimmunoassay, Total Thyroxine
- CDPRadioimmunoassay, Total Triiodothyronine
- JHIVisual, Pregnancy Hcg, Prescription Use
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