FDA product code CFJ: Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase
CFJ is the FDA product code for nad reduction/nadh oxidation, lactate dehydrogenase. It is a Class II device, regulated under 21 CFR 862.1440 and reviewed by the Clinical Chemistry panel. FDA has cleared 111 510(k) submissions under CFJ, from 67 different applicants. The average 510(k) review took 44 days (median 37). FDA has posted 8 recalls for CFJ devices.
Classification
| Field | Value |
|---|---|
| Device name | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase |
| Device class | Class II |
| Regulation | 21 CFR 862.1440 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every CFJ clearance
Top CFJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Em Diagnostic Systems, Inc. | 10 | 1993-12-16 |
| Beckman Instruments, Inc. | 4 | 1983-07-19 |
| Harleco | 4 | 1981-09-24 |
| J.T. Baker Chemical Co. | 4 | 1977-01-05 |
| Pointe Scientific, Inc., | 3 | 1997-10-08 |
62 more applicants have CFJ clearances. See the full list in Caduvo.
Most recent CFJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K131975 | Alfa Wassermann Diagnostic Technologies, Inc. | ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, ACE LDH-L REAGENT | 2013-10-02 | 96 |
| K091544 | Alfa Wassermann, Inc. | S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017 | 2009-09-09 | 105 |
| K051108 | Abaxis, Inc. | PICCOLO LACTATE DEPHYDROGENASE TEST SYSTEM | 2005-07-08 | 67 |
| K974859 | Diagnostic Chemicals , Ltd. | LACTANE DEHYDROGENASE-SL ASSAY, CATALOGUE NUMBER 327-10, 327-30 | 1998-01-22 | 24 |
| K973589 | Pointe Scientific, Inc., | LIQUID LDH-L REAGENT SET | 1997-10-08 | 16 |
Recalls for CFJ devices
8 product recalls in 7 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2020-08-11.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2018 | 1 |
| 2020 | 2 |
Frequently asked questions
What is FDA product code CFJ?
CFJ is the FDA product code for nad reduction/nadh oxidation, lactate dehydrogenase. It is a Class II device, regulated under 21 CFR 862.1440 and reviewed by the Clinical Chemistry panel.
What device class is CFJ?
Class II, regulation 21 CFR 862.1440. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code CFJ?
Across 111 cleared submissions the average was 44 days from receipt to decision (median 37).
Which companies have the most CFJ clearances?
Em Diagnostic Systems, Inc. (10); Beckman Instruments, Inc. (4); Harleco (4); J.T. Baker Chemical Co. (4); Pointe Scientific, Inc., (3).
Have CFJ devices been recalled?
Yes: 8 product recalls across 7 recall events; the most recent began 2020-08-11.
Next steps
- Run an FDA pathway report with predicate devices for product code CFJ
- Run a recall and safety report across every CFJ manufacturer
- Watch product code CFJ 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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