510(k) K002674
- Device
- RANDOX MICROALBUMIN
- Applicant
- RANDOX LABORATORIES, LTD.
- 510(k) number
- K002674
- Product code
- DDZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2000-10-05
- Date received
- 2000-08-28
- Regulation
- 866.5040
- Classification name
- Albumin, Fitc, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- PAULINE ARMSTRONG
- Address
- 55 Diamond Rd. Crumlin, Co. Antrim IE BT29 4QY BT29 4QY
FDA Registration Numbers#
- 3013660430
- 3014607865
- 3013059683
- 3019906
- 3004493545
- 1827821
- 3009189893
- 3013530901
- 9610099
- 3017379203
- 2432235
- 3003423869
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DDZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K050576 | MICROALBUMIN TIA REAGENT; MALB CALIBRATOR SET 200; MALB CONTROL-L, CONTROL-H | Good Biotech Corp. | 2005-04-21 |
| K023860 | MICROALBUMIN REAGENT SET AND CALIBRATORS | Pointe Scientific, Inc., | 2003-04-28 |
| K831902 | FLUORESCEIN CONJUGATED IMMUNOGLOBIN- | Dako Corp. | 1983-07-18 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases