510(k) K102643
- Device
- SPOTCHECK NEONATAL GALT MICROPLATE REAGENT KIT
- Applicant
- ASTORIA-PACIFIC,INC.
- 510(k) number
- K102643
- Product code
- KQP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2011-07-15
- Date received
- 2010-09-14
- Regulation
- 862.1315
- Classification name
- Fluorescent Proc. (qual.), Galactose-1-phosphate Uridyl Transferase
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JASON C REYNOLDS
- Address
- 15130 SE 82nd Dr. Clackamas OR US 97015 97015
FDA Registration Numbers#
- 3050015
- 8043909
Source Documents#
Other 510(k) Records For Product Code KQP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K101392 | NEOPAC SOFTWARE, 3007 DIGITAL PHOTOMETER/FLUOROMETER MODEL NA, 307 AND 350D | Astoria-Pacific, Inc. | 2011-02-04 |
| K100101 | GSP NEONATALGALT KIT, MODEL 3303-001U | Perkinelmer, Inc. | 2010-06-11 |
| K993536 | BIO-RAD CODA NEONATAL GALT ASSAY | Bio-Rad | 1999-11-04 |
| K990827 | MICROPLATE NEONATAL GALT ASSAY | Bio-Rad | 1999-04-09 |
| K970277 | URIDYLTRANSFERASE KIT, 50 HOUR (80-4000-13K) | Astoria-Pacific, Inc. | 1997-12-11 |
| K894011 | TOTAL GALACTOSE | Alpkem Corp. | 1990-01-11 |
Legacy Summary#
summary
FDA Review#
Decision Summary