Plasma Fibrinogen Control Level 1/LEVEL 2
FDA 510(k) K935598 · Clinical Controls, Inc.
510(k) numberK935598
Submission
- Device name
- Plasma Fibrinogen Control Level 1/LEVEL 2
- Applicant
- Clinical Controls, Inc.
Grover Beach, CA, US - Received
- November 19, 1993
- Decision date
- May 2, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GIL – Plasma, Fibrinogen Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7340
- Specialty
- Hematology
Other 510(k)s with product code GIL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K962407 | N/T Protein Control PyGIL · Traditional | Behring Diagnostics, Inc. | 07/29/1996SE |
| K946265 | Fibrinogen High Abnormal Control - Level 3GIL · Traditional | Clinical Controls, Inc. | 08/24/1995SE |
| K946193 | Fibrinogen Control (Human) Level 1, 2, 3GIL · Traditional | More Diagnostics | 08/24/1995SE |
| K951012 | N/T Protein Control PyGIL · Traditional | Behring Diagnostics, Inc. | 04/17/1995SE |
| K934741 | Liquid Fibrinogen FDP Control Level 1 & 2GIL · Traditional | Clinical Controls, Inc. | 09/08/1994SE |
| K915462 | Fibrinogen ControlGIL · Traditional | Sigma Diagnostics, Inc. | 03/04/1992SE |
| K833352 | Gen. Diagnostics Low Fibrinogen ControlGIL · Traditional | Warner-Lambert Co. | 11/03/1983SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K012907 | Liquispx Liquid Saliva or Unrine Drug of Abuse ControlDIF · Traditional | 09/28/2001SE |
| K964278 | Whole Blood Glucose Control Level 1,2,AND 3/WHOLE Blood Glucose Linearity…JJX · Traditional | 11/22/1996SE |
| K962432 | Liquispex Urine (Micro)Albumin ControlJJX · Traditional | 07/05/1996SE |
| K955691 | Serum Volatiles Control Level 1 & 2JJY · Traditional | 04/24/1996SE |
| K955690 | Aqueous Ethanol/Ammonia Control Level 1, 2, & 3JJY · Traditional | 04/24/1996SE |
| K946265 | Fibrinogen High Abnormal Control - Level 3GIL · Traditional | 08/24/1995SE |
| K946266 | Ferritin Control - Level 1, 2, 3DGD · Traditional | 02/10/1995SE |
| K946050 | Liquispex(Tm) Liquid CRP Control Level 1 and 2DCK · Traditional | 02/10/1995SE |
| K946049 | Liquispex(Tm) Liquid B2M/CRP Control Level 1 and 2JJY · Traditional | 02/10/1995SE |
| K946048 | Liquispex(Tm) Liquid B2M Control Level 1 and 2JZG · Traditional | 02/10/1995SE |
Questions and answers
When was Plasma Fibrinogen Control Level 1/LEVEL 2 cleared by the FDA?
Plasma Fibrinogen Control Level 1/LEVEL 2 (K935598) received a 510(k) decision of Substantially Equivalent on May 2, 1995, 529 days after the submission was received.
What is the product code of K935598?
The FDA product code is GIL – Plasma, Fibrinogen Control, a Class II (moderate risk) device regulated under 21 CFR 864.7340.