510(k) K023860
- Device
- MICROALBUMIN REAGENT SET AND CALIBRATORS
- Applicant
- POINTE SCIENTIFIC, INC.
- 510(k) number
- K023860
- Product code
- DDZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-04-28
- Date received
- 2002-11-20
- 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
- RON JAMISON
- Address
- 1025 John A. Papalas Dr. Lincoln Park MI US 48146 48146
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 |
| K002674 | RANDOX MICROALBUMIN | Randox Laboratories, Ltd. | 2000-10-05 |
| K831902 | FLUORESCEIN CONJUGATED IMMUNOGLOBIN- | Dako Corp. | 1983-07-18 |
Legacy Summary#
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FDA Review#
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