FDA product code KNK: Acid, Uric, Uricase (Colorimetric)
KNK is the FDA product code for acid, uric, uricase (colorimetric). It is a Class I device, regulated under 21 CFR 862.1775 and reviewed by the Clinical Chemistry panel. FDA has cleared 118 510(k) submissions under KNK, from 79 different applicants. The average 510(k) review took 59 days (median 42). FDA has posted 15 recalls for KNK devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Acid, Uric, Uricase (Colorimetric) |
| Device class | Class I |
| Regulation | 21 CFR 862.1775 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KNK clearance
Top KNK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Em Diagnostic Systems, Inc. | 6 | 1991-09-27 |
| Boehringer Mannheim Corp. | 5 | 1989-10-23 |
| Abbott Laboratories | 4 | 2011-05-06 |
| Wako Chemicals USA, Inc. | 4 | 1999-11-09 |
| Roche Diagnostic Systems, Inc. | 4 | 1992-07-09 |
74 more applicants have KNK clearances. See the full list in Caduvo.
Most recent KNK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K102568 | Abbott Laboratories | URIC ACID MODEL 3P39 | 2011-05-06 | 241 |
| K062862 | Olympus America, Inc. | OLYMPUS URIC ACID REAGENT, MODEL OSR6X98 | 2007-04-06 | 193 |
| K040467 | Clinical Data, Inc. | VITALAB URIC ACID REAGENT | 2004-03-08 | 13 |
| K031044 | Clinical Data, Inc. | ATAC PAK URIC ACID REAGENT AND ATAC CALIBRATOR | 2003-07-15 | 105 |
| K022096 | Bayer Diagnostics Corp. | URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM | 2003-03-18 | 264 |
Recalls for KNK devices
15 product recalls in 12 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2026-04-02.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2018 | 1 |
| 2019 | 1 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code KNK?
KNK is the FDA product code for acid, uric, uricase (colorimetric). It is a Class I device, regulated under 21 CFR 862.1775 and reviewed by the Clinical Chemistry panel.
What device class is KNK?
Class I, regulation 21 CFR 862.1775. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KNK?
Across 118 cleared submissions the average was 59 days from receipt to decision (median 42).
Which companies have the most KNK clearances?
Em Diagnostic Systems, Inc. (6); Boehringer Mannheim Corp. (5); Abbott Laboratories (4); Wako Chemicals USA, Inc. (4); Roche Diagnostic Systems, Inc. (4).
Have KNK devices been recalled?
Yes: 15 product recalls across 12 recall events; the most recent began 2026-04-02.
Next steps
- Run an FDA pathway report with predicate devices for product code KNK
- Run a recall and safety report across every KNK manufacturer
- Watch product code KNK 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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