Data / Medical devices / Netherlands / Iq Products B.V.
Iq Products B.V.: FDA-registered device maker in Groningen, Netherlands, 1 510(k) clearance
Iq Products B.V. is registered with the FDA (registration 9681582) in Groningen, Netherlands. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 12, 1999. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 9681582
- FEI number
- 3002807541
- Address
- Rozenburglaan 13a, Groningen, Netherlands, 9727DL
- Owner or operator
- IQ PRODUCTS B.V. (9025233)
- Roles
- Manufacturer
- First device listed
- March 22, 1996
- Registered through
- 2027
- Brand names listed
- Anti-HbF1 Dy-410, Anti-HbF1 FITC, Anti-HbF1 R-PE, Anti-HbF1 purified, Anti-HbS FITC, Anti-panHb APC, CD163 Biotin (MAC2-158), CD163 FITC (MAC2-158) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Antisera, Conjugated Fluorescent, Cytomegalovirus | LIN | 2 | Manufacturer | accessdata.fda.gov |
| Reagents, Specific, Analyte | MVU | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 12, 1999 | K991650 | CMV BRITE TURBO KIT | LIN | Substantially Equivalent | Biotest Diagnostics Corp. | accessdata.fda.gov |
Compare with other makers
Updated July 12, 1999. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.