Du Pont Analyst Thyroid Rotor
FDA 510(k) K884169 · The DU Pont Co.
510(k) numberK884169
Submission
- Device name
- Du Pont Analyst Thyroid Rotor
- Applicant
- The DU Pont Co.
Wilmington, DE, US - Received
- October 4, 1988
- Decision date
- January 24, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CEL – Ammonium Molybdate And Ammonium Vanadate, Phospholipids
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1575
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CEL
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| 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 |
| K884168 | Analyst Thyroxine (T4) & Thyronine Uptake Calibra.JIS · Traditional | 11/29/1988SE |
Questions and answers
When was Du Pont Analyst Thyroid Rotor cleared by the FDA?
Du Pont Analyst Thyroid Rotor (K884169) received a 510(k) decision of Substantially Equivalent on January 24, 1989, 112 days after the submission was received.
What is the product code of K884169?
The FDA product code is CEL – Ammonium Molybdate And Ammonium Vanadate, Phospholipids, a Class I (low risk) device regulated under 21 CFR 862.1575.