Acticlot Protein S, Model 843L
FDA 510(k) K012386 · American Diagnostica, Inc.
510(k) numberK012386
Submission
- Device name
- Acticlot Protein S, Model 843L
- Applicant
- American Diagnostica, Inc.
Greenwich, CT, US - Received
- July 27, 2001
- Decision date
- September 14, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GGP – Test, Qualitative And Quantitative Factor Deficiency
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7290
- Specialty
- Hematology
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| K940490 | DV Test and DVV ConfirmGIR · Traditional | 04/05/1995SE |
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Questions and answers
When was Acticlot Protein S, Model 843L cleared by the FDA?
Acticlot Protein S, Model 843L (K012386) received a 510(k) decision of Substantially Equivalent on September 14, 2001, 49 days after the submission was received.
What is the product code of K012386?
The FDA product code is GGP – Test, Qualitative And Quantitative Factor Deficiency, a Class II (moderate risk) device regulated under 21 CFR 864.7290.