Apparatus, General Use, Thin Layer Chromatography
The General Use Apparatus for Thin Layer Chromatography encompasses equipment and accessories used in laboratory thin-layer chromatography procedures for the separation and analysis of compounds in clinical chemistry settings. It is a Class 1 device subject to general controls only and does not require premarket notification. The product code is DPA, regulated under 21 CFR 862.2270, within the Clinical Chemistry specialty. It is GMP exempt, indicating reduced manufacturing quality system requirements apply.
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Basic Information
- Product Code
- DPA
- Device Class
- FDA class 1
- Regulation Number
- 862.2270
- Medical Specialty
- Clinical Chemistry
- Review Panel
- TX
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K904326 | DE-TOX TUBES A AND DE-TOX TUBES B | Jan 17, 1991 | Substantially Equivalent | Dyna-Tek Industries |
| K884176 | CHROMATOGRAPHY KIT | Apr 04, 1989 | Substantially Equivalent | Gelman Sciences, Inc. |
| K791431 | TECHNICON FAST-LC SYS. FOR THEOPHYLLINE | Oct 11, 1979 | Substantially Equivalent | Technicon Instruments Corp. |
| K770765 | REAGENT SET, RENORPACE | Jun 24, 1977 | Substantially Equivalent | G.D. Searle and Co. |
| K760908 | MINIATURE ASCENDING PAPER CHROMATO- | Nov 19, 1976 | Substantially Equivalent | Ackerman Nuclear, Inc. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.