FDA product code JJQ: Colorimeter, Photometer, Spectrophotometer For Clinical Use
JJQ is the FDA product code for colorimeter, photometer, spectrophotometer for clinical use. It is a Class I device, regulated under 21 CFR 862.2300 and reviewed by the Clinical Chemistry panel. FDA has cleared 258 510(k) submissions under JJQ, from 125 different applicants. The average 510(k) review took 71 days (median 46). FDA has posted 17 recalls for JJQ devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
| Device class | Class I |
| Regulation | 21 CFR 862.2300 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JJQ clearance
Top JJQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Dynatech Laboratories, Inc. | 15 | 1994-10-20 |
| Bio-Tek Instruments, Inc. | 14 | 1995-10-25 |
| Awareness Technology, Inc. | 8 | 1998-01-28 |
| Lkb Instruments, Inc. | 7 | 1986-04-24 |
| Varian Assoc., Inc. | 7 | 1984-09-26 |
120 more applicants have JJQ clearances. See the full list in Caduvo.
Most recent JJQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K013371 | Otsuka Pharmaceutical Co., Ltd. | UBIT-IR300 INFRARED SPECTROMETRY SYSTEM | 2001-12-21 | 71 |
| K980120 | Digene Corp. | DIGENE DML 2000 MICROPLATE LUMINOMETER | 1998-02-06 | 24 |
| K973938 | Sfri, Inc. | ALPHA 4 LS AUTOMATED MICROTITERPLATE PROCESSOR AND READER | 1998-02-04 | 112 |
| K974762 | Awareness Technology, Inc. | STAT TRACKS | 1998-01-28 | 40 |
| K962113 | Columbia Bioscience, Inc. | ANTHOS PHACTS VERSION MICROPLATE READER | 1996-11-05 | 158 |
Recalls for JJQ devices
17 product recalls in 10 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2025-09-23.
| Year | Recalls |
|---|---|
| 2022 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code JJQ?
JJQ is the FDA product code for colorimeter, photometer, spectrophotometer for clinical use. It is a Class I device, regulated under 21 CFR 862.2300 and reviewed by the Clinical Chemistry panel.
What device class is JJQ?
Class I, regulation 21 CFR 862.2300. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JJQ?
Across 258 cleared submissions the average was 71 days from receipt to decision (median 46).
Which companies have the most JJQ clearances?
Dynatech Laboratories, Inc. (15); Bio-Tek Instruments, Inc. (14); Awareness Technology, Inc. (8); Lkb Instruments, Inc. (7); Varian Assoc., Inc. (7).
Have JJQ devices been recalled?
Yes: 17 product recalls across 10 recall events; the most recent began 2025-09-23.
Next steps
- Run an FDA pathway report with predicate devices for product code JJQ
- Run a recall and safety report across every JJQ manufacturer
- Watch product code JJQ 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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