Specktin-La Test Set
FDA 510(k) K961892 · Analytical Control Systems, Inc.
510(k) numberK961892
Submission
- Device name
- Specktin-La Test Set
- Applicant
- Analytical Control Systems, Inc.
Fishers, IN, US - Received
- May 16, 1996
- Decision date
- March 7, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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.
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|---|---|---|
| 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 |
| K913249 | Acs ULTRA-1 ThromboplastinGJS · Traditional | 12/04/1991SE |
Questions and answers
When was Specktin-La Test Set cleared by the FDA?
Specktin-La Test Set (K961892) received a 510(k) decision of Substantially Equivalent on March 7, 1997, 295 days after the submission was received.
What is the product code of K961892?
The FDA product code is GFO – Activated Partial Thromboplastin, a Class II (moderate risk) device regulated under 21 CFR 864.7925.