The following data is part of a premarket notification filed by Dyna-tek Industries with the FDA for De-tox Tubes A And De-tox Tubes B.
Device ID | K904326 |
510k Number | K904326 |
Device Name: | DE-TOX TUBES A AND DE-TOX TUBES B |
Classification | Apparatus, General Use, Thin Layer Chromatography |
Applicant | DYNA-TEK INDUSTRIES 8971 HALL DR. Lenexa, KS 66219 |
Contact | Paul Sood |
Correspondent | Paul Sood DYNA-TEK INDUSTRIES 8971 HALL DR. Lenexa, KS 66219 |
Product Code | DPA |
CFR Regulation Number | 862.2270 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-09-20 |
Decision Date | 1991-01-17 |