STRATUS THYROID UPTAKE FLUOROMETRIC
FDA 510(k) clearance K834209 · decided 1984-03-09
Clearance details
- K-number
- K834209
- Device name
- STRATUS THYROID UPTAKE FLUOROMETRIC
- Applicant
- American Dade
- Decision
- Substantially Equivalent
- Date received
- 1983-12-05
- Decision date
- 1984-03-09
- Days to decision
- 95 days
- Clearance type
- Traditional
- Product code
- KHQ
- Device class
- 2
- Regulation number
- 862.1715
- 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 |
|---|---|---|
| ACE T UPTAKE REAGENT TU CALIBRATORS (K981375) | Schiapparelli Biosystems, Inc. | 1998-06-10 |
| T-UPTAKE MICROPLATE EIA (K980088) | Monobind | 1998-02-04 |
| CHIRON DIAGNOSTICS ACS:180TU P (K970539) | Chiron Diagnostics Corp. | 1997-03-24 |
| VITROS IMMUNODIAGNOSTICS PRODUCTS T3 UPTAKE REAGENT PACK (GEM.1025) AND T3 UPTAKE CALIBRATORS (GEM.C025) (K964308) | Johnson & Johnson Clinical Diagnostics, Inc. | 1996-11-27 |
| ELECSYS T-UPTAKE ASSAY (K961488) | Boehringer Mannheim Corp. | 1996-06-12 |
| CEDIA T UPTAKE ASSAY (K954807) | Boehringer Mannheim Corp. | 1995-12-21 |
| T-UPTAKE EIA TEST (K951586) | Diagnostic Reagents, Inc. | 1995-05-15 |
| STRATUS(R) THYROID UPTAKE FLUOR ENZYME IMMUNOASSAY (K933414) | Baxter Diagnostics, Inc. | 1994-11-22 |
| AXSYM(TM) T-UPTAKE (K934312) | Abbott Laboratories | 1994-06-21 |
| VIDAS T UPTAKE (K935816) | Biomerieux Vitek, Inc. | 1994-03-22 |
| T3 UPTAKE CHEMILUMINESCENCE ASSAY (K926220) | Nichols Institute Diagnostics | 1993-11-17 |
| IQ TUPTAKE ASSAY (K931294) | Becton Dickinson Advanced Diagnostics | 1993-07-22 |
Recalls involving this device
No recalls on record reference this clearance.