Aptt-Es
FDA 510(k) K935169 · Helena Laboratories
510(k) numberK935169
Submission
- Device name
- Aptt-Es
- Applicant
- Helena Laboratories
Beaumont, TX, US - Received
- October 26, 1993
- Decision date
- December 2, 1994
- 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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| K050221 | Hemosil Silica Clotting TimeGFO · Traditional | Instrumentation Laboratory CO | 03/30/2005SE |
| K022021 | Vital Scientific Aptt, Aptt & Quikcoag ApttGFO · Traditional | Vital Scientific N.V. | 11/01/2002SE |
| K014028 | Careside ApttGFO · Traditional | Careside Hemotology, Inc. | 02/08/2002SE |
| K014008 | Hemochron Jr. Citrate Aptt CuvetteGFO · Special | Itc, Inc. | 01/24/2002SE |
| K992712 | Sigma Diagnostics Alexin LS, Models A1219, A1334GFO · Traditional | Sigma Diagnostics, Inc. | 12/06/1999SE |
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Questions and answers
When was Aptt-Es cleared by the FDA?
Aptt-Es (K935169) received a 510(k) decision of Substantially Equivalent on December 2, 1994, 402 days after the submission was received.
What is the product code of K935169?
The FDA product code is GFO – Activated Partial Thromboplastin, a Class II (moderate risk) device regulated under 21 CFR 864.7925.