Acs Human Plasma Coagulation Control Level I
FDA 510(k) K893784 · Analytical Control Systems, Inc.
510(k) numberK893784
Submission
- Device name
- Acs Human Plasma Coagulation Control Level I
- Applicant
- Analytical Control Systems, Inc.
Fishers, IN, US - Received
- May 22, 1989
- Decision date
- June 23, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GIZ – Plasma, Control, Normal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5425
- Specialty
- Hematology
Other 510(k)s with product code GIZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K060968 | Stasis - I, II and III; Serathan - a, B; Intrin - Ea, Si Calcium Chloride 0.02M…GIZ · Traditional | Wortham Laboratories, Inc. | 05/15/2007SE |
| K042941 | Dade Behring Heparin Calibrator and ControlsGIZ · Traditional | Dade Behring, Inc. | 12/02/2004SE |
| K023309 | Control Plasma NGIZ · Traditional | Dade Behring, Inc. | 11/01/2002SE |
| K013708 | Reference Check, Catalog NUMBER-RCN-10GIZ · Traditional | Precision Biologic | 12/10/2001SE |
| K003328 | Accuclot Control I, Model A4089GIZ · Traditional | Sigma Diagnostics, Inc. | 03/01/2001SE |
| K001256 | Control Plasma NGIZ · Traditional | Dade Behring, Inc. | 05/24/2000SE |
| K984129 | Coagulation Control Level 1 (Normal)GIZ · Traditional | Pacific Hemostasis | 12/01/1998SE |
| K973274 | Accucolor High Calibrator (A3089)GIZ · Traditional | Sigma Diagnostics, Inc. | 10/31/1997SE |
| K961814 | Thrombolytic Assessment System Prothrombin Time Test ControlsGIZ · Traditional | Cardiovascular Diagnostics, Inc. | 08/13/1996SE |
| K941737 | Specialty Assayed CONTROL-1GIZ · Traditional | Helena Laboratories | 10/07/1994SE |
More from Helena Laboratories
| 510(k) | Device | Decision |
|---|---|---|
| K961892 | Specktin-La Test SetGFO · Traditional | 03/07/1997SE |
| K941115 | Acs Cardio-Trol ControlJJY · Traditional | 07/20/1994SE |
| K940272 | Acs Normal Angiotensin Converting Enzyme ControlJJX · Traditional | 04/20/1994SE |
| K940397 | Acs O Dilvent Protein Dilution MatrixJJY · Traditional | 03/11/1994SE |
| K930477 | Acs Angiotensin Converting Enzyme (Ace) CalibratorJIS · Traditional | 06/07/1993SE |
| K926012 | Acs Apct Reagent, ModifiedGFO · Traditional | 04/27/1993SE |
| K925340 | Coagulation Control Containing HemoglobinJPA · Traditional | 03/23/1993SE |
| K925906 | Normal Angiotensin Converting Enzyme ControlJJX · Traditional | 02/18/1993SE |
| K921223 | Acs Freeze-Dried Aptt ReagentGFO · Traditional | 08/18/1992SE |
| K921118 | Acs Apct ReagentGFO · Traditional | 07/28/1992SE |
Questions and answers
When was Acs Human Plasma Coagulation Control Level I cleared by the FDA?
Acs Human Plasma Coagulation Control Level I (K893784) received a 510(k) decision of Substantially Equivalent on June 23, 1989, 32 days after the submission was received.
What is the product code of K893784?
The FDA product code is GIZ – Plasma, Control, Normal, a Class II (moderate risk) device regulated under 21 CFR 864.5425.