Immulite HGH
FDA 510(k) K955376 · Diagnostic Products Corp.
510(k) numberK955376
Submission
- Device name
- Immulite HGH
- Applicant
- Diagnostic Products Corp.
Los Angeles, CA, US - Received
- November 24, 1995
- Decision date
- February 16, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CFL – Radioimmunoassay, Human Growth Hormone
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1370
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CFL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K972761 | Sealite Sciences, Inc. Aqualite Human Growth Hormone AssayCFL · Traditional | Sealite Sciences, Inc. | 09/25/1997SE |
| K971353 | DSL Active Non-Extraction Igf-I ElisaCFL · Traditional | Diagnostic Systems Laboratories, Inc. | 05/12/1997SE |
| K970701 | DSL 1900 Active Human Growth Hormone Irma (DSL 1900)CFL · Traditional | Diagnostic Systems Laboratories, Inc. | 04/02/1997SE |
| K962758 | DSL 9100 Igf-Ii IrmaCFL · Traditional | Diagnostic Systems Laboratories, Inc. | 08/30/1996SE |
| K961678 | Human Growth Hormone Immunoassay KitCFL · Traditional | Nichols Institute Diagnostics | 07/08/1996SE |
| 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 |
| 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 |
| K946247 | IGFBP-3; Insulin-Like Growth Factor Binding PROTEIN-3CFL · Traditional | Nichols Institute | 06/23/1995SE |
More from Nichols Institute
| 510(k) | Device | Decision |
|---|---|---|
| K063057 | Immulite/Immulite 1000, Immulite 2000 High Sensitivity CRPNQD · Abbreviated | 12/22/2006SE |
| K063045 | Immulite 2000, Immulite 2500 VancomycinLEH · Traditional | 12/05/2006SE |
| K060929 | Immulite 2500 Vitamin B12 Model L5KVB2-200 TEST,L5KVB6-600 Test, Immulite 2500 Folic…CDD · Special | 04/28/2006SE |
| K053533 | Immulite/Immulite 1000 Turbo Intact PTHCEW · Traditional | 02/03/2006SE |
| K034055 | Immulite 2500 Ck-Mb, 2500 Myoglobin, 2500 Stat Troponin IJHX · Special | 01/21/2004SE |
| K033234 | Immulite 2500 Automated Immunoassay AnalyzerDHA · Traditional | 12/12/2003SE |
| K032881 | Immulite/Immulite 1000 Total Testosterone and Immulite 2000 Total TestosteroneCDZ · Special | 10/10/2003SE |
| K023152 | Immulite 2000 Allergen-Specific IgeDHB · Abbreviated | 12/17/2002SE |
| K023304 | Immulite/Immulite 1000 Calcitonin, Model LKCL and Immulite 2000 Calcitonin, Model L2KCLJKR · Traditional | 12/09/2002SE |
| K022603 | Immulite 1000 Automated Immunoassay AnalyzerCEW · Special | 08/21/2002SE |
Questions and answers
When was Immulite HGH cleared by the FDA?
Immulite HGH (K955376) received a 510(k) decision of Substantially Equivalent on February 16, 1996, 84 days after the submission was received.
What is the product code of K955376?
The FDA product code is CFL – Radioimmunoassay, Human Growth Hormone, a Class I (low risk) device regulated under 21 CFR 862.1370.