510(k) K904326
- Device
- DE-TOX TUBES A AND DE-TOX TUBES B
- Applicant
- DYNA-TEK INDUSTRIES
- 510(k) number
- K904326
- Product code
- DPA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-01-17
- Date received
- 1990-09-20
- Regulation
- 862.2270
- Classification name
- Apparatus, General Use, Thin Layer Chromatography
- Medical specialty
- Clinical Chemistry
- Review panel
- Toxicology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- PAUL SOOD
- Address
- 8971 Hall Dr. Lenexa KS US 66219 66219
FDA Registration Numbers#
- 2245285
- 1932270
- 3002800697
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DPA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K884176 | CHROMATOGRAPHY KIT | Gelman Sciences, Inc. | 1989-04-04 |
| K791431 | TECHNICON FAST-LC SYS. FOR THEOPHYLLINE | Technicon Instruments Corp. | 1979-10-11 |
| K770765 | REAGENT SET, RENORPACE | G.D. Searle and Co. | 1977-06-24 |
| K760908 | MINIATURE ASCENDING PAPER CHROMATO- | Ackerman Nuclear, Inc. | 1976-11-19 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases