London Diagnostics Lumatag(R) HGH Chem Immun Assay
FDA 510(k) K912858 · London Diagnostics, Inc.
510(k) numberK912858
Submission
- Device name
- London Diagnostics Lumatag(R) HGH Chem Immun Assay
- Applicant
- London Diagnostics, Inc.
Eden Prairie, MN, US - Received
- June 28, 1991
- Decision date
- July 30, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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
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| 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 |
| 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 |
More from Nichols Institute
| 510(k) | Device | Decision |
|---|---|---|
| K914835 | Lumatag Free T4 Chemiluminescence AssayCEC · Traditional | 12/17/1991SE |
| K911985 | Lumatag T4 Chemiluminescence AssayCDX · Traditional | 08/02/1991SE |
| K905814 | Lumatag(R) FSH Chemiluminescence Immunometri AssayCGJ · Traditional | 02/04/1991SE |
| K904458 | Lumatag(Tm) Prolactin Diagnostic Kit/ModificationCFT · Traditional | 10/12/1990SE |
| K903130 | London Diagnostics Lumatag(Tm) Intact PTH AssayCEW · Traditional | 09/25/1990SE |
| K903195 | London Diagnostics Lumatag (R) Ige Chem. Imm AssayDGC · Traditional | 08/02/1990SE |
| K902443 | Lumatag(Tm) LH Diagnostic KitCEP · Traditional | 08/02/1990SE |
| K901484 | Lumatag(Tm) HCG Chemiluminescence ImmunometricJHI · Traditional | 05/01/1990SE |
| K901075 | Lumatag(Tm) Ferritin Chemiluminescence Immunomet.DBF · Traditional | 04/02/1990SE |
| K881443 | Lumatag(Tm) TSH Chemiluminescence Immuno. AssayJLW · Traditional | 05/27/1988SE |
Questions and answers
When was London Diagnostics Lumatag(R) HGH Chem Immun Assay cleared by the FDA?
London Diagnostics Lumatag(R) HGH Chem Immun Assay (K912858) received a 510(k) decision of Substantially Equivalent on July 30, 1991, 32 days after the submission was received.
What is the product code of K912858?
The FDA product code is CFL – Radioimmunoassay, Human Growth Hormone, a Class I (low risk) device regulated under 21 CFR 862.1370.