Quest Intl., Inc.
North Miami, FL, US
Quest Intl., Inc. appears in FDA device records in North Miami, FL. FDA records list 25 510(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
- 25
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 25 510(k) clearances for Quest Intl., Inc. between 1989 and 2009. The busiest year on record is 1998, with 7. The most recent is 2009, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1989 | 2 |
| 1996 | 3 |
| 1997 | 3 |
| 1998 | 7 |
| 1999 | 4 |
| 2000 | 1 |
| 2003 | 2 |
| 2004 | 2 |
| 2009 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K091260 | SERAQUEST EBV EA-D IGG TEST | LSE | Substantially Equivalent | |
| K033915 | MODIFICATION TO SERAQUEST EB VCA IGG | LSE | Substantially Equivalent | |
| K033780 | MODIFICATION TO SERAQUEST VCA IGM | LJN | Substantially Equivalent | |
| K023593 | SERAQUEST ANTI-THYROID PEROXIDASE (TPO) | JZO | Substantially Equivalent | |
| K023592 | SERAQUEST ANTI-THYROGLOBULIN | DDC | Substantially Equivalent | |
| K003069 | ANTI-CARDIOLIPIN, MULTIPLE AUTOANTIBODIES IMMUNOLOGICAL TEST SYSTEM | MID | Substantially Equivalent | |
| K991975 | SERAQUEST EB NA IGG | LSE | Substantially Equivalent | |
| K990410 | SERAQUEST EB VCA IGG | LSE | Substantially Equivalent | |
| K990977 | SERAQUEST EB VAC IGM | LJN | Substantially Equivalent | |
| K982485 | SERAQUEST CMV IGM | LFZ | Substantially Equivalent | |
| K982281 | SERAQUEST RUBELLA IGM | LFX | Substantially Equivalent | |
| K980639 | SERAQUEST ANTI-SSB | LLL | Substantially Equivalent | |
| K980540 | SERAQUEST ANTI-SM | LKP | Substantially Equivalent | |
| K980811 | SERAQUEST ANTI-SM/RNP | LKP | Substantially Equivalent | |
| K980810 | SERAQUEST ANTI-SSA | LJM | Substantially Equivalent | |
| K980391 | SERAQUEST ANTI-DSDNA | LRM | Substantially Equivalent | |
| K980059 | SERAQUEST MUMPS IGG | LJY | Substantially Equivalent | |
| K972295 | SERAQUEST VZV IGG | LFY | Substantially Equivalent | |
| K971672 | SERAQUEST TOXOPLASMA IGM | LGD | Substantially Equivalent | |
| K963282 | SERAQUEST HSV IGG | LGC | Substantially Equivalent | |
| K961053 | SERAQUEST RUBELLA IGG | LFX | Substantially Equivalent | |
| K960092 | SERAQUEST TOXOPLASMA IGG | LGD | Substantially Equivalent | |
| K954191 | SERAQUEST CMV IGG | LFZ | Substantially Equivalent | |
| K891736 | PATIENT EXAMINATION GLOVES (LATEX) | LYY | Substantially Equivalent | |
| K890356 | LATEX EXAMINATION GLOVES NON-STERILE | LYY | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- LRMAnti-Dna Antibody (Enzyme-Labeled), Antigen, Control
- LKPAnti-Sm Antibody, Antigen And Control
- LJNAntibody Igm, If, Epstein-Barr Virus
- LJMAntinuclear Antibody (Enzyme-Labeled), Antigen, Controls
- LFZEnzyme Linked Immunoabsorbent Assay, Cytomegalovirus
- LGCEnzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
- LJYEnzyme Linked Immunoabsorbent Assay, Mumps Virus
- LFXEnzyme Linked Immunoabsorbent Assay, Rubella
- LGDEnzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
- LFYEnzyme Linked Immunoabsorbent Assay, Varicella-Zoster
- LSEEpstein-Barr Virus, Other
- LLLExtractable Antinuclear Antibody, Antigen And Control
- LYYLatex Patient Examination Glove
- MIDSystem, Test, Anticardiolipin Immunological
- JZOSystem, Test, Thyroid Autoantibody
- DDCThyroglobulin, Antigen, Antiserum, Control
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain