FDA product code KQP: Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase
KQP is the FDA product code for fluorescent proc. (qual.), galactose-1-phosphate uridyl transferase. It is a Class II device, regulated under 21 CFR 862.1315 and reviewed by the Clinical Chemistry panel. FDA has cleared 7 510(k) submissions under KQP, from 4 different applicants. The average 510(k) review took 186 days (median 219). FDA has posted 1 recall for KQP devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase |
| Device class | Class II |
| Regulation | 21 CFR 862.1315 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every KQP clearance
Top KQP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Astoria-Pacific, Inc. | 3 | 2011-07-15 |
| Bio-Rad | 2 | 1999-11-04 |
| Perkinelmer, Inc. | 1 | 2010-06-11 |
| Alpkem Corp. | 1 | 1990-01-11 |
Most recent KQP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K102643 | Astoria-Pacific, Inc. | SPOTCHECK NEONATAL GALT MICROPLATE REAGENT KIT | 2011-07-15 | 304 |
| K101392 | Astoria-Pacific, Inc. | NEOPAC SOFTWARE, 3007 DIGITAL PHOTOMETER/FLUOROMETER MODEL NA, 307 AND 350D | 2011-02-04 | 262 |
| K100101 | Perkinelmer, Inc. | GSP NEONATALGALT KIT, MODEL 3303-001U | 2010-06-11 | 149 |
| K993536 | Bio-Rad | BIO-RAD CODA NEONATAL GALT ASSAY | 1999-11-04 | 16 |
| K990827 | Bio-Rad | MICROPLATE NEONATAL GALT ASSAY | 1999-04-09 | 28 |
Recalls for KQP devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2026-05-18.
| Year | Recalls |
|---|---|
| 2026 | 1 |
Frequently asked questions
What is FDA product code KQP?
KQP is the FDA product code for fluorescent proc. (qual.), galactose-1-phosphate uridyl transferase. It is a Class II device, regulated under 21 CFR 862.1315 and reviewed by the Clinical Chemistry panel.
What device class is KQP?
Class II, regulation 21 CFR 862.1315. Typical premarket route: 510(k).
How long does a 510(k) take for product code KQP?
Across 7 cleared submissions the average was 186 days from receipt to decision (median 219).
Which companies have the most KQP clearances?
Astoria-Pacific, Inc. (3); Bio-Rad (2); Perkinelmer, Inc. (1); Alpkem Corp. (1).
Have KQP devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2026-05-18.
Next steps
- Run an FDA pathway report with predicate devices for product code KQP
- Run a recall and safety report across every KQP manufacturer
- Watch product code KQP for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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