N/T Protein Control Py
FDA 510(k) K962407 · Behring Diagnostics, Inc.
510(k) numberK962407
Submission
- Device name
- N/T Protein Control Py
- Applicant
- Behring Diagnostics, Inc.
Westwood, MA, US - Received
- June 21, 1996
- Decision date
- July 29, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|---|
| 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 |
| K935598 | Plasma Fibrinogen Control Level 1/LEVEL 2GIL · Traditional | Clinical Controls, Inc. | 05/02/1995SE |
| 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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| K971600 | Emit Calibrator B Level 1 (Cutoff)/Emit Calibrator B Level 2 (High)DKB · Traditional | 06/25/1997SE |
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| K964595 | Opus Psa Test SystemLTJ · Traditional | 06/24/1997SE |
Questions and answers
When was N/T Protein Control Py cleared by the FDA?
N/T Protein Control Py (K962407) received a 510(k) decision of Substantially Equivalent on July 29, 1996, 38 days after the submission was received.
What is the product code of K962407?
The FDA product code is GIL – Plasma, Fibrinogen Control, a Class II (moderate risk) device regulated under 21 CFR 864.7340.