DE-TOX TUBES A AND DE-TOX TUBES B
FDA 510(k) clearance K904326 · decided 1991-01-17
Clearance details
- K-number
- K904326
- Device name
- DE-TOX TUBES A AND DE-TOX TUBES B
- Applicant
- Dyna-Tek Industries
- Decision
- Substantially Equivalent
- Date received
- 1990-09-20
- Decision date
- 1991-01-17
- Days to decision
- 119 days
- Clearance type
- Traditional
- Product code
- DPA
- Device class
- 1
- Regulation number
- 862.2270
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Lenexa, KS, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CHROMATOGRAPHY KIT (K884176) | Gelman Sciences, Inc. | 1989-04-04 |
| TECHNICON FAST-LC SYS. FOR THEOPHYLLINE (K791431) | Technicon Instruments Corp. | 1979-10-11 |
| REAGENT SET, RENORPACE (K770765) | G.D. Searle and Co. | 1977-06-24 |
| MINIATURE ASCENDING PAPER CHROMATO- (K760908) | Ackerman Nuclear, Inc. | 1976-11-19 |
Recalls involving this device
No recalls on record reference this clearance.