Harleco Brand Clinicard Lipase Test Set
FDA 510(k) K791922 · Dade, Baxter Travenol Diagnostics, Inc.
510(k) numberK791922
Submission
- Device name
- Harleco Brand Clinicard Lipase Test Set
- Applicant
- Dade, Baxter Travenol Diagnostics, Inc.
Mchenry, IL, US - Received
- September 26, 1979
- Decision date
- November 27, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CET – Olive Oil Emulsion (Turbidimetric), Lipase
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1465
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CET
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K970124 | Lipase Reagent Set (Colipase Method)CET · Traditional | Teco Diagnostics | 03/06/1997SE |
| K940457 | Lipase Reagent SystemCET · Traditional | Medical Diagnostic Technologies, Inc. | 06/02/1994SE |
| K915706 | Lipase Reagent SetCET · Traditional | Tech Intl. Co. | 02/18/1992SE |
| K901858 | Modified Labeling for Aca Lipase Analytical TestCET · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 06/12/1990SE |
| K893718 | Deltatest (R) Lipase IICET · Traditional | Electro-Nucleonics, Inc. | 09/28/1989SE |
| K885078 | Lipase SR Liquid Stable Reagent SetCET · Traditional | Medical Analysis Systems, Inc. | 03/13/1989SE |
| K864438 | Beckman Epsilon(Tm) Lipase Test KitCET · Traditional | Beckman Instruments, Inc. | 03/12/1987SE |
| K862440 | Paramax Lipase ReagentCET · Traditional | American Dade | 08/04/1986SE |
| K844240 | Enzygnost Lipase TestCET · Traditional | Behring Diagnostics, Inc. | 02/12/1985SE |
| K823860 | Nuclipase (I125) Pancreatic LipaseCET · Traditional | Nuclear Diagnostics, Inc. | 04/18/1983SE |
More from Nuclear Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K800296 | Whole Blood Gas Control, Levels 1,2,&3GGM · Traditional | 03/05/1980SE |
| K792606 | Whole Blood Platelet Control Normal,JPK · Traditional | 02/13/1980SE |
| K792723 | Blood Fluid FiltersJKA · Traditional | 01/21/1980SE |
| K792607 | T3 Uptake (T3U) ReagentsKHQ · Traditional | 01/16/1980SE |
| K792443 | TSH RadioimmunoassayJLW · Traditional | 12/27/1979SE |
| K792442 | Ferritin RadioimmunoassayDBF · Traditional | 12/18/1979SE |
| K792183 | Dade High Density Lipoprotein CholesteroLBS · Traditional | 11/13/1979SE |
| K790776 | Dade Low Ionic Strength Soluition (Liss)KSG · Traditional | 05/23/1979SE |
| K790767 | Immu-Tek Automatic CentrifugeKSN · Traditional | 05/23/1979SE |
| K790571 | Quik-StainIAF · Traditional | 04/23/1979SE |
Questions and answers
When was Harleco Brand Clinicard Lipase Test Set cleared by the FDA?
Harleco Brand Clinicard Lipase Test Set (K791922) received a 510(k) decision of Substantially Equivalent on November 27, 1979, 62 days after the submission was received.
What is the product code of K791922?
The FDA product code is CET – Olive Oil Emulsion (Turbidimetric), Lipase, a Class I (low risk) device regulated under 21 CFR 862.1465.