The following data is part of a premarket notification filed by Pointe Scientific, Inc. with the FDA for Microalbumin Reagent Set And Calibrators.
| Device ID | K023860 |
| 510k Number | K023860 |
| Device Name: | MICROALBUMIN REAGENT SET AND CALIBRATORS |
| Classification | Albumin, Fitc, Antigen, Antiserum, Control |
| Applicant | POINTE SCIENTIFIC, INC. 1025 JOHN A. PAPALAS DR. Lincoln Park, MI 48146 |
| Contact | Ron Jamison |
| Correspondent | Ron Jamison POINTE SCIENTIFIC, INC. 1025 JOHN A. PAPALAS DR. Lincoln Park, MI 48146 |
| Product Code | DDZ |
| CFR Regulation Number | 866.5040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-11-20 |
| Decision Date | 2003-04-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811727011893 | K023860 | 000 |
| 00811727011886 | K023860 | 000 |