Fiagen TBG Time-Resolved Fluoroimmunoassay Kit
FDA 510(k) K884201 · Cyberfluor, Inc.
510(k) numberK884201
Submission
- Device name
- Fiagen TBG Time-Resolved Fluoroimmunoassay Kit
- Applicant
- Cyberfluor, Inc.
Ontario M5t 1x4, CA - Received
- October 6, 1988
- Decision date
- December 14, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CEE – Radioimmunoassay, Thyroxine-Binding Globulin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1685
- Specialty
- Clinical Chemistry
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| K885034 | T-Uptake MicroassayCEE · Traditional | Diamedix Corp. | 02/02/1989SE |
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| K862109 | Enzymun Test TBGCEE · Traditional | Boehringer Mannheim Corp. | 06/30/1986SE |
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| K900621 | Fiagen(Tm) Hlh.SCEP · Traditional | 03/01/1990SE |
| K895186 | Fiagen T3 Uptake Catalogue #101-402KHQ · Traditional | 11/08/1989SE |
| K895396 | Cyberfluor Fiagen TSHJLW · Traditional | 10/31/1989SE |
| K884708 | Fiagen HFSH Time-Resolved Fluoroimmunoassay KitCGJ · Traditional | 01/17/1989SE |
| K884707 | Fiagen Digoxin Time-Resolved Fluoroimmunoassay KitLCS · Traditional | 01/17/1989SE |
| K883182 | Fiagen Rubella IggLFX · Traditional | 10/31/1988SE |
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Questions and answers
When was Fiagen TBG Time-Resolved Fluoroimmunoassay Kit cleared by the FDA?
Fiagen TBG Time-Resolved Fluoroimmunoassay Kit (K884201) received a 510(k) decision of Substantially Equivalent on December 14, 1988, 69 days after the submission was received.
What is the product code of K884201?
The FDA product code is CEE – Radioimmunoassay, Thyroxine-Binding Globulin, a Class II (moderate risk) device regulated under 21 CFR 862.1685.