CLP Activated Partial Thromboplastin Time Test
FDA 510(k) K881068 · Creative Laboratory Products, Inc.
510(k) numberK881068
Submission
- Device name
- CLP Activated Partial Thromboplastin Time Test
- Applicant
- Creative Laboratory Products, Inc.
Indianapolis, IN, US - Received
- March 14, 1988
- Decision date
- March 23, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GFO – Activated Partial Thromboplastin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7925
- Specialty
- Hematology
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More from Sigma Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K950589 | CLP High Level High Density Lipo Protein Cholesterol Control-HlJJX · Traditional | 03/20/1995SE |
| K942284 | CLP Total Iron and Uibc/Tibc Linearity Control SetJJX · Traditional | 08/26/1994SE |
| K922995 | Lipid ControlsJJX · Traditional | 08/12/1992SE |
| K913427 | Sickle Hemoglobin (Hba/S) Control SetJCM · Traditional | 11/19/1991SE |
| K913371 | Total Iron and Unsat Iron Bind Capac/Iron Bind CalJIT · Traditional | 11/08/1991SE |
| K913585 | Lipase Linearity ControlJJX · Traditional | 10/21/1991SE |
| K913224 | Lipid Linearity ControlsJJY · Traditional | 09/25/1991SE |
| K913496 | Cholinesterase Linearity ControlJJX · Traditional | 09/11/1991SE |
| K912823 | High Density Lipoprotein CholesterolLBR · Traditional | 08/16/1991SE |
| K912725 | Total Iron & Unsat Iron Bind Cap/Iron Bind ControlJJY · Traditional | 07/30/1991SE |
Questions and answers
When was CLP Activated Partial Thromboplastin Time Test cleared by the FDA?
CLP Activated Partial Thromboplastin Time Test (K881068) received a 510(k) decision of Substantially Equivalent on March 23, 1988, 9 days after the submission was received.
What is the product code of K881068?
The FDA product code is GFO – Activated Partial Thromboplastin, a Class II (moderate risk) device regulated under 21 CFR 864.7925.