QM300 Control F Pack
FDA 510(k) K883712 · Kallestad Diag, A Div. of Erbamont, Inc.
510(k) numberK883712
Submission
- Device name
- QM300 Control F Pack
- Applicant
- Kallestad Diag, A Div. of Erbamont, Inc.
Chaska, MN, US - Received
- August 30, 1988
- Decision date
- September 22, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DFC – Lipoprotein, Low-Density, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5600
- Specialty
- Immunology
Other 510(k)s with product code DFC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253069 | Lipoprotein (a) Molarity AssayDFC · Traditional | Diazyme Laboratories, Inc. | 06/16/2026SE |
| K241220 | Tina-quant Lipoprotein(a) Gen.2 MolarityDFC · Traditional | Roche Diagnostics Operations | 01/24/2025SE |
| K211058 | Lp(a) UltraDFC · Traditional | SENTINEL CH. SpA | 12/22/2022SE |
| K180074 | Diazyme Lipoprotein (a) AssayDFC · Traditional | Diazyme Laboratories, Inc. | 03/22/2018SE |
| K123046 | Advia Chemistry Lipoprotein(A) Reagent Advia Chemistry Lipoprotein(A) CalibratorDFC · Traditional | Siemens Healthcare Diagnostics, Inc. | 12/20/2012SE |
| K122722 | Cobas C Tina-Quant Lipoprotein (a) Gen 2 Assay Model 05852625190; Preciset LP (a) Gen 2…DFC · Traditional | Roche Diagnostics | 11/29/2012SE |
| K082488 | Diazyme Lp(A) AssayDFC · Traditional | General Atomics | 01/13/2009SE |
| K063838 | Lipoprotein(A), Lipoprotein(A) Calibrator, Lipoprotein (a) Control, Control HighDFC · Traditional | Thermo Electron OY | 09/27/2007SE |
| K050487 | Quantia La(A)DFC · Traditional | Biokit, S.A. | 04/26/2005SE |
| K023853 | K-Assay Lp(A) ControlsDFC · Traditional | Kamiya Biomedical Co. | 12/13/2002SE |
More from Kamiya Biomedical Co.
| 510(k) | Device | Decision |
|---|---|---|
| K910887 | QM300 Control G PackGTQ · Traditional | 06/17/1991SE |
| K910886 | QM300 Antistreptolysin O (Aso) Antigen PackGTQ · Traditional | 06/17/1991SE |
| K910885 | QM300 Calibrator G PackGTQ · Traditional | 06/17/1991SE |
| K904725 | Chlamydia System Software (CSS)LJC · Traditional | 01/14/1991SE |
| K902253 | Pathfinder(Tm) Chlamydia Microplate KitLJC · Traditional | 07/26/1990SE |
| K902462 | Modified QM300 Rheumatoid Factor TestDHR · Traditional | 06/21/1990SE |
| K900010 | NDS Cortisol Test Kit and NDS Cortisol CalibratorJFT · Traditional | 04/03/1990SE |
| K900009 | NDS Theophylline Test Kit & NDS TDM Calibrator SetKLS · Traditional | 03/29/1990SE |
| K897072 | NDS Thyroxine Test Kit & NDS Thyroxine CalibratorKLI · Traditional | 03/29/1990SE |
| K894947 | Platelia Toxo Igg KitLGO · Traditional | 03/23/1990SE |
Questions and answers
When was QM300 Control F Pack cleared by the FDA?
QM300 Control F Pack (K883712) received a 510(k) decision of Substantially Equivalent on September 22, 1988, 23 days after the submission was received.
What is the product code of K883712?
The FDA product code is DFC – Lipoprotein, Low-Density, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5600.