Fiagen(Tm) HLH Catalogue Number: 102-301
FDA 510(k) K874624 · Cyberfluor, Inc.
510(k) numberK874624
Submission
- Device name
- Fiagen(Tm) HLH Catalogue Number: 102-301
- Applicant
- Cyberfluor, Inc.
Ontario M5t 1x4, CA - Received
- November 10, 1987
- Decision date
- January 11, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CEP – Radioimmunoassay, Luteinizing Hormone
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1485
- Specialty
- Clinical Chemistry
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| K991386 | Early Ovulation Predictor (Stick), One Step Ovulation Predictor (Stick), Ovulation…CEP · Traditional | Selfcare, Inc. | 05/25/1999SE |
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| K923410 | Fiagen ProgesteroneJLS · Traditional | 12/03/1992SE |
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| K904539 | Flagen TM Free T4CEC · Traditional | 11/30/1990SE |
| 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 |
| K884201 | Fiagen TBG Time-Resolved Fluoroimmunoassay KitCEE · Traditional | 12/14/1988SE |
| K883182 | Fiagen Rubella IggLFX · Traditional | 10/31/1988SE |
Questions and answers
When was Fiagen(Tm) HLH Catalogue Number: 102-301 cleared by the FDA?
Fiagen(Tm) HLH Catalogue Number: 102-301 (K874624) received a 510(k) decision of Substantially Equivalent on January 11, 1988, 62 days after the submission was received.
What is the product code of K874624?
The FDA product code is CEP – Radioimmunoassay, Luteinizing Hormone, a Class I (low risk) device regulated under 21 CFR 862.1485.