Acs Animal Plasma Coagulation Control Level II
FDA 510(k) K893971 · Analytical Control Systems, Inc.
510(k) numberK893971
Submission
- Device name
- Acs Animal Plasma Coagulation Control Level II
- Applicant
- Analytical Control Systems, Inc.
Fishers, IN, US - Received
- June 2, 1989
- Decision date
- July 25, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GGC – Control, Plasma, Abnormal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5425
- Specialty
- Hematology
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| K062306 | Plasmacon N, Plasmacon L-1, Plasmacon L-2GGC · Traditional | R2 Diagnostics, Inc. | 03/16/2007SE |
| K061803 | Sta - Control la 1+2GGC · Traditional | Diagnostica Stago, Inc. | 07/28/2006SE |
| K032804 | Cryocheck Weak Lupus Positive ControlGGC · Traditional | Precision Biologic | 11/03/2003SE |
| K023312 | Control Plasma PGGC · Traditional | Dade Behring, Inc. | 11/01/2002SE |
| K020878 | Lyphochek Hemostasis, Models 798, 799GGC · Traditional | Bio-Rad | 04/15/2002SE |
| K020109 | Sigma Diagnostics Accuclot la ControlGGC · Traditional | Sigma Diagnostics, Inc. | 02/06/2002SE |
| K012422 | K-Assay D-Dimer ControlsGGC · Traditional | Kamiya Biomedical Co. | 08/21/2001SE |
| K003329 | Sigma Dianostics Auto D-Dimer Control Level 2, Model A5217GGC · Traditional | Sigma Diagnostics, Inc. | 03/01/2001SE |
More from Sigma Diagnostics, Inc.
| 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 Animal Plasma Coagulation Control Level II cleared by the FDA?
Acs Animal Plasma Coagulation Control Level II (K893971) received a 510(k) decision of Substantially Equivalent on July 25, 1989, 53 days after the submission was received.
What is the product code of K893971?
The FDA product code is GGC – Control, Plasma, Abnormal, a Class II (moderate risk) device regulated under 21 CFR 864.5425.