Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase
This device is a qualitative fluorescent procedure for galactose-1-phosphate uridyl transferase (GALT), an in vitro diagnostic test used to screen for galactosemia, an inherited metabolic disorder that impairs the processing of galactose. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. The product code is KQP, regulated under 21 CFR 862.1315 within the Clinical Chemistry specialty. This device is eligible for third-party review.
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Basic Information
- Product Code
- KQP
- Device Class
- FDA class 2
- Regulation Number
- 862.1315
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K102643 | SPOTCHECK NEONATAL GALT MICROPLATE REAGENT KIT | Jul 15, 2011 | Substantially Equivalent | Astoria-Pacific, Inc. |
| K101392 | NEOPAC SOFTWARE, 3007 DIGITAL PHOTOMETER/FLUOROMETER MODEL NA, 307 AND 350D | Feb 04, 2011 | Substantially Equivalent | Astoria-Pacific, Inc. |
| K100101 | GSP NEONATALGALT KIT, MODEL 3303-001U | Jun 11, 2010 | Substantially Equivalent | Perkinelmer, Inc. |
| K993536 | BIO-RAD CODA NEONATAL GALT ASSAY | Nov 04, 1999 | Substantially Equivalent | Bio-Rad |
| K990827 | MICROPLATE NEONATAL GALT ASSAY | Apr 09, 1999 | Substantially Equivalent | Bio-Rad |
| K970277 | URIDYLTRANSFERASE KIT, 50 HOUR (80-4000-13K) | Dec 11, 1997 | Substantially Equivalent | Astoria-Pacific, Inc. |
| K894011 | TOTAL GALACTOSE | Jan 11, 1990 | Substantially Equivalent | Alpkem Corp. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.