Platelin L
FDA 510(k) K921396 · Organon Teknika Corp.
510(k) numberK921396
Submission
- Device name
- Platelin L
- Applicant
- Organon Teknika Corp.
Durham, NC, US - Received
- March 23, 1992
- Decision date
- October 19, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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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| K992712 | Sigma Diagnostics Alexin LS, Models A1219, A1334GFO · Traditional | Sigma Diagnostics, Inc. | 12/06/1999SE |
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Questions and answers
When was Platelin L cleared by the FDA?
Platelin L (K921396) received a 510(k) decision of Substantially Equivalent on October 19, 1992, 210 days after the submission was received.
What is the product code of K921396?
The FDA product code is GFO – Activated Partial Thromboplastin, a Class II (moderate risk) device regulated under 21 CFR 864.7925.