Fiagen HGH Fluoroimmunoassay Kit
FDA 510(k) K882823 · Cyberfluor, Inc.
510(k) numberK882823
Submission
- Device name
- Fiagen HGH Fluoroimmunoassay Kit
- Applicant
- Cyberfluor, Inc.
Ontario M5t 1x4, CA - Received
- July 8, 1988
- Decision date
- August 30, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CFL – Radioimmunoassay, Human Growth Hormone
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1370
- Specialty
- Clinical Chemistry
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| K971353 | DSL Active Non-Extraction Igf-I ElisaCFL · Traditional | Diagnostic Systems Laboratories, Inc. | 05/12/1997SE |
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| K962758 | DSL 9100 Igf-Ii IrmaCFL · Traditional | Diagnostic Systems Laboratories, Inc. | 08/30/1996SE |
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| K961172 | DSL Active Non-Extraction Igf-I IrmaCFL · Traditional | Diagnostic Systems Laboratories, Inc. | 04/23/1996SE |
| K960551 | DSL Active Human Growth Hormone ElisaCFL · Traditional | Diagnostic Systems Laboratories, Inc. | 03/06/1996SE |
| K955376 | Immulite HGHCFL · Traditional | Diagnostic Products Corp. | 02/16/1996SE |
| K955390 | Insulin-Like Growth Factor-I (Igf-I) Immunoradiometric AssayCFL · Traditional | Corning Nichols Diagnostics | 12/29/1995SE |
| K952505 | Insulin-Like Growth Factor I (Igf-I), Immunoradiometeric Assay (Irma)CFL · Traditional | Nichols Institute | 07/03/1995SE |
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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 |
| 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 HGH Fluoroimmunoassay Kit cleared by the FDA?
Fiagen HGH Fluoroimmunoassay Kit (K882823) received a 510(k) decision of Substantially Equivalent on August 30, 1988, 53 days after the submission was received.
What is the product code of K882823?
The FDA product code is CFL – Radioimmunoassay, Human Growth Hormone, a Class I (low risk) device regulated under 21 CFR 862.1370.