Monobind, Inc.
Lake Forest, CA, US
MONOBIND, INC. appears in FDA device records in Lake Forest, CA. FDA records list 23 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 23 510(k) clearances for Monobind, Inc. between 1977 and 2018. The busiest year on record is 1997, with 7. The most recent is 2018, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1977 | 3 |
| 1978 | 1 |
| 1982 | 2 |
| 1983 | 1 |
| 1986 | 1 |
| 1992 | 2 |
| 1993 | 1 |
| 1997 | 7 |
| 1998 | 1 |
| 2002 | 1 |
| 2003 | 1 |
| 2008 | 1 |
| 2018 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K181017 | Free Testosterone AccuBind ELISA Test System | CDZ | Substantially Equivalent | |
| K063437 | ACCUBIND NEO-TSH MICROWELL ELISA, MODEL 3425-300 | JLW | Substantially Equivalent | |
| K030860 | ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300 | KLI | Substantially Equivalent | |
| K020548 | FREE T4 (THYTOXINE) MICROPLATE EIA TEST MODELS # 1225-300 | CEC | Substantially Equivalent | |
| K980088 | T-UPTAKE MICROPLATE EIA | KHQ | Substantially Equivalent | |
| K972720 | FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300) | CGJ | Substantially Equivalent | |
| K971835 | ANTI-THYROGLOBULIN (TG) MICROPLATE ELISA | DDC | Substantially Equivalent | |
| K971834 | ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISA | JNL | Substantially Equivalent | |
| K971921 | PROLACTIN (PRL) HORMONE MICROPLATE ELISA | CFT | Substantially Equivalent | |
| K971780 | THYROTROPIN(TSH) ELISA | JLW | Substantially Equivalent | |
| K971779 | TOTAL TRIIODOTHYRONINE(T3) MICROPLATE EIA | CDP | Substantially Equivalent | |
| K971709 | TOTAL THROXINE MICROPLATE EIA(225-300) | KLI | Substantially Equivalent | |
| K926345 | TRIODOTHYRONINE (TC) COATED TUBE RIA | CDP | Substantially Equivalent | |
| K922353 | DIGOXIN COATED TUBE RIA | LCS | Substantially Equivalent | |
| K921935 | THYROXINE (T4) COATED TUBE RIA | CDX | Substantially Equivalent | |
| K854958 | HCG RIA TEST SYSTEM | JHI | Substantially Equivalent | |
| K830412 | RADIOIMMUNOASSAY TEST SYSTEM PRL | CFT | Substantially Equivalent | |
| K820760 | LH RADIOIMMUNOASSAY TEST SYSTEM | CEP | Substantially Equivalent | |
| K820048 | FSH RADIOIMMUNOASSAY TEST SYSTEM | CGJ | Substantially Equivalent | |
| K780361 | T3 UPTAKE TEST | KHQ | Substantially Equivalent | |
| K771222 | TSH RIA TEST SYSTEM | JLW | Substantially Equivalent | |
| K771221 | T4 RIA TEST SYSTEM | CDX | Substantially Equivalent | |
| K771220 | T3 RIA TEST SYSTEM | CDP | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2020726 | 2020726 | MONOBIND, INC. | 100 N. POINTE DR., Lake Forest, CA 92630 US | 2026 | and 55 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CGNAcid, Folic, Radioimmunoassay
- JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use
- MVEBiosensor, Immunoassay, Myoglobin
- JJQColorimeter, Photometer, Spectrophotometer For Clinical Use
- JHYColorimetric Method, Cpk Or Isoenzymes
- GIFDiluent, Blood Cell
- KXTEnzyme Immunoassay, Digoxin
- KLIEnzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
- LFZEnzyme Linked Immunoabsorbent Assay, Cytomegalovirus
- LFXEnzyme Linked Immunoabsorbent Assay, Rubella
- LGDEnzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
- MXJEnzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
- LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
- DAPFibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
- LYRHelicobacter Pylori
- MMIImmunoassay Method, Troponin Subunit
- JNLImmunochemical, Thyroglobulin Autoantibody
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- LTJProstate-Specific Antigen (Psa) For Management Of Prostate Cancers
- KHQRadioassay, Triiodothyronine Uptake
- CDDRadioassay, Vitamin B12
- JMGRadioimmunoassay (Two-Site Solid Phase), Ferritin
- JLXRadioimmunoassay, 17-Hydroxyprogesterone
- CKGRadioimmunoassay, Acth
- CJMRadioimmunoassay, Aldosterone
- CIZRadioimmunoassay, Androstenedione
- JKDRadioimmunoassay, C-Peptides Of Proinsulin
- JKRRadioimmunoassay, Calcitonin
- CGRRadioimmunoassay, Cortisol
- JKCRadioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)
- LCSRadioimmunoassay, Digoxin (125-I)
- CHPRadioimmunoassay, Estradiol
- CGIRadioimmunoassay, Estriol
- CGFRadioimmunoassay, Estrone
- CGJRadioimmunoassay, Follicle-Stimulating Hormone
- CECRadioimmunoassay, Free Thyroxine
- CFLRadioimmunoassay, Human Growth Hormone
- CFQRadioimmunoassay, Immunoglobulins (G, A, M)
- CFPRadioimmunoassay, Immunoreactive Insulin
- CEPRadioimmunoassay, Luteinizing Hormone
- CEWRadioimmunoassay, Parathyroid Hormone
- JLSRadioimmunoassay, Progesterone
- CFTRadioimmunoassay, Prolactin (Lactogen)
- CDZRadioimmunoassay, Testosterones And Dihydrotestosterone
- JLWRadioimmunoassay, Thyroid-Stimulating Hormone
- CEERadioimmunoassay, Thyroxine-Binding Globulin
- CDXRadioimmunoassay, Total Thyroxine
- CDPRadioimmunoassay, Total Triiodothyronine
- DCNSystem, Test, C-Reactive Protein
- DHXSystem, Test, Carcinoembryonic Antigen
- DHASystem, Test, Human Chorionic Gonadotropin
- MOISystem, Test, Immunological, Antigen, Tumor
- DHRSystem, Test, Rheumatoid Factor
- MSWSystem, Test, Thyroglobulin
- MRGSystem, Test, Vitamin D
- LTKTest, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
- MTGTest, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
- DDCThyroglobulin, Antigen, Antiserum, Control
- DDGTransferrin, Antigen, Antiserum, Control
- 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