Chemelia Free THYROXINE(FT4)/ENZYME Immuno. (Eia)
FDA 510(k) K874875 · Boots-Celltech Diagnostics, Inc.
510(k) numberK874875
Submission
- Device name
- Chemelia Free THYROXINE(FT4)/ENZYME Immuno. (Eia)
- Applicant
- Boots-Celltech Diagnostics, Inc.
East Hanover, NJ, US - Received
- November 27, 1987
- Decision date
- March 24, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CEC – Radioimmunoassay, Free Thyroxine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1695
- Specialty
- Clinical Chemistry
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| K140859 | Dimension Vista Free Thyroxine Flex Reagent Cartridge, FT4, Dimension Vista Thyroid…CEC · Traditional | Siemens Healthcare Diagnostics, Inc. | 11/26/2014SE |
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| K871877 | Ideia Herpes Simplex Virus TestLGC · Traditional | 11/17/1989SE |
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| K872958 | Imagen Influenza Virus a and B TestmiGNX · Traditional | 02/24/1988SE |
| K872843 | Oveia (TM) Dual AnalyteJLP · Traditional | 02/02/1988SE |
| K873625 | Chemelia Enzyme Immunoassay for (TSH)JLM · Traditional | 10/20/1987SE |
| K872056 | Modified (Directions for Use) for Ideia(Tm) TestLJC · Traditional | 06/15/1987SE |
| K870602 | Imagen Herpes Simplex Virus (HSV) Typing TestGQN · Traditional | 05/08/1987SE |
| K864998 | Ideia(Tm) Chlamydia Specimen Collection KitJSM · Traditional | 04/20/1987SE |
| K864539 | Modified Imagen(Tm) Chlamydia TestLJP · Traditional | 03/12/1987SE |
Questions and answers
When was Chemelia Free THYROXINE(FT4)/ENZYME Immuno. (Eia) cleared by the FDA?
Chemelia Free THYROXINE(FT4)/ENZYME Immuno. (Eia) (K874875) received a 510(k) decision of Substantially Equivalent on March 24, 1988, 118 days after the submission was received.
What is the product code of K874875?
The FDA product code is CEC – Radioimmunoassay, Free Thyroxine, a Class II (moderate risk) device regulated under 21 CFR 862.1695.