Activated Partial Thromboplastin Time
FDA 510(k) K915463 · Sigma Diagnostics, Inc.
510(k) numberK915463
Submission
- Device name
- Activated Partial Thromboplastin Time
- Applicant
- Sigma Diagnostics, Inc.
St. Louis, MO, US - Received
- December 4, 1991
- Decision date
- January 23, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GGW – Test, Time, Partial Thromboplastin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7925
- Specialty
- Hematology
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Questions and answers
When was Activated Partial Thromboplastin Time cleared by the FDA?
Activated Partial Thromboplastin Time (K915463) received a 510(k) decision of Substantially Equivalent on January 23, 1992, 50 days after the submission was received.
What is the product code of K915463?
The FDA product code is GGW – Test, Time, Partial Thromboplastin, a Class II (moderate risk) device regulated under 21 CFR 864.7925.