TECHNICON FAST-LC SYS. FOR THEOPHYLLINE
FDA 510(k) clearance K791431 · decided 1979-10-11
Clearance details
- K-number
- K791431
- Device name
- TECHNICON FAST-LC SYS. FOR THEOPHYLLINE
- Applicant
- Technicon Instruments Corp.
- Decision
- Substantially Equivalent
- Date received
- 1979-07-26
- Decision date
- 1979-10-11
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- DPA
- Device class
- 1
- Regulation number
- 862.2270
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Mchenry, IL, 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 |
|---|---|---|
| DE-TOX TUBES A AND DE-TOX TUBES B (K904326) | Dyna-Tek Industries | 1991-01-17 |
| CHROMATOGRAPHY KIT (K884176) | Gelman Sciences, Inc. | 1989-04-04 |
| 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.