FDA product code DPA: Apparatus, General Use, Thin Layer Chromatography
DPA is the FDA product code for apparatus, general use, thin layer chromatography. It is a Class I device, regulated under 21 CFR 862.2270 and reviewed by the Clinical Toxicology panel. FDA has cleared 5 510(k) submissions under DPA, from 5 different applicants. The average 510(k) review took 92 days (median 77).
Classification
| Field | Value |
|---|---|
| Device name | Apparatus, General Use, Thin Layer Chromatography |
| Device class | Class I |
| Regulation | 21 CFR 862.2270 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every DPA clearance
Top DPA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Dyna-Tek Industries | 1 | 1991-01-17 |
| Gelman Sciences, Inc. | 1 | 1989-04-04 |
| Technicon Instruments Corp. | 1 | 1979-10-11 |
| G.D. Searle and Co. | 1 | 1977-06-24 |
| Ackerman Nuclear, Inc. | 1 | 1976-11-19 |
Most recent DPA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K904326 | Dyna-Tek Industries | DE-TOX TUBES A AND DE-TOX TUBES B | 1991-01-17 | 119 |
| K884176 | Gelman Sciences, Inc. | CHROMATOGRAPHY KIT | 1989-04-04 | 182 |
| K791431 | Technicon Instruments Corp. | TECHNICON FAST-LC SYS. FOR THEOPHYLLINE | 1979-10-11 | 77 |
| K770765 | G.D. Searle and Co. | REAGENT SET, RENORPACE | 1977-06-24 | 58 |
| K760908 | Ackerman Nuclear, Inc. | MINIATURE ASCENDING PAPER CHROMATO- | 1976-11-19 | 24 |
Recalls for DPA devices
openFDA lists no recalls for product code DPA.
Frequently asked questions
What is FDA product code DPA?
DPA is the FDA product code for apparatus, general use, thin layer chromatography. It is a Class I device, regulated under 21 CFR 862.2270 and reviewed by the Clinical Toxicology panel.
What device class is DPA?
Class I, regulation 21 CFR 862.2270. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code DPA?
Across 5 cleared submissions the average was 92 days from receipt to decision (median 77).
Which companies have the most DPA clearances?
Dyna-Tek Industries (1); Gelman Sciences, Inc. (1); Technicon Instruments Corp. (1); G.D. Searle and Co. (1); Ackerman Nuclear, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DPA
- Run a recall and safety report across every DPA manufacturer
- Watch product code DPA 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.
All Clinical Toxicology product codes · FDA product code lookup · 510(k) database search · 510(k) review times