Analyst Thyroxine (T4) & Thyronine Uptake Calibra.
FDA 510(k) K884168 · The DU Pont Co.
510(k) numberK884168
Submission
- Device name
- Analyst Thyroxine (T4) & Thyronine Uptake Calibra.
- Applicant
- The DU Pont Co.
Wilmington, DE, US - Received
- October 4, 1988
- Decision date
- November 29, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JIS – Calibrator, Primary
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1150
- Specialty
- Clinical Chemistry
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| K032608 | Gonotec Calibration Solution 300 Mosmol/Kg for OsmometerJIS · Abbreviated | Gonotec Gesellschaft Fuer Mess-Und Regeltechnik MB | 10/21/2003SE |
| K032296 | Vitros Immunodiagnostic Products Progestrone Reagent Pack and CalibratorsJIS · Special | Ortho-Clinical Diagnostics, Inc. | 08/13/2003SE |
| K030964 | Calibration Plasma LMW HeparinJIS · Traditional | Instrumentation Laboratory CO | 06/06/2003SE |
| K030546 | CRP (II) CalibratorsJIS · Traditional | Denka Seiken Co., Ltd. | 06/02/2003SE |
| K030320 | Wako Autokit Micro Albumin, Wako Autokit Micro Calibrator Set, Micro Albumin Control SetJIS · Traditional | Wako Chemicals USA, Inc. | 04/11/2003SE |
More from Wako Chemicals USA, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K953477 | Modular Daylight Cassette for Video ImagingLMC · Traditional | 10/07/1995SE |
| K953475 | CDS Compact Daylight Cassette for Video ImagingLMC · Traditional | 10/07/1995SE |
| K952891 | Cronex Low Absorption CassetteIXA · Traditional | 07/13/1995SE |
| K945125 | Dupont Aca Vancomycin (Vanc) MethodLEH · Traditional | 03/10/1995SE |
| K943704 | Lipase CalibratorJIT · Traditional | 09/14/1994SE |
| K900492 | Labeling Change - Viaspan(Tm) (Belzer Uw)KDL · Traditional | 03/20/1990SE |
| K885259 | Aca Thyronine Uptake (Tu E) MethodKHQ · Traditional | 02/17/1989SE |
| K885258 | Aca Thyroxine (T4 E) MethodKLI · Traditional | 02/17/1989SE |
| K884700 | Analyst Thyroxine (T4) RotorKLI · Traditional | 01/27/1989SE |
| K884169 | Du Pont Analyst Thyroid RotorCEL · Traditional | 01/24/1989SE |
Questions and answers
When was Analyst Thyroxine (T4) & Thyronine Uptake Calibra. cleared by the FDA?
Analyst Thyroxine (T4) & Thyronine Uptake Calibra. (K884168) received a 510(k) decision of Substantially Equivalent on November 29, 1988, 56 days after the submission was received.
What is the product code of K884168?
The FDA product code is JIS – Calibrator, Primary, a Class II (moderate risk) device regulated under 21 CFR 862.1150.