SAS Francisella Tularensis Antiserum
FDA 510(k) K952141 · Sa Scientific, Inc.
510(k) numberK952141
Submission
- Device name
- SAS Francisella Tularensis Antiserum
- Applicant
- Sa Scientific, Inc.
San Antonio, TX, US - Received
- May 8, 1995
- Decision date
- July 21, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GSK – Antiserum, Francisella Tularensis
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3280
- Specialty
- Microbiology
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| K041441 | SAS Influenza a TestPSZ · Traditional | 07/22/2004SE |
| K041439 | SAS Influenza B TestPSZ · Traditional | 07/22/2004SE |
| K030628 | SAS RSV Control KitJJX · Traditional | 03/17/2003SE |
| K022845 | SAS RSV TestGQG · Traditional | 01/29/2003SE |
| K022683 | SAS Blood/Serum/Urine/Urine HCGJHI · Traditional | 12/16/2002SE |
| K023270 | SAS StrepalertGTY · Traditional | 10/17/2002SE |
Questions and answers
When was SAS Francisella Tularensis Antiserum cleared by the FDA?
SAS Francisella Tularensis Antiserum (K952141) received a 510(k) decision of Substantially Equivalent on July 21, 1995, 74 days after the submission was received.
What is the product code of K952141?
The FDA product code is GSK – Antiserum, Francisella Tularensis, a Class II (moderate risk) device regulated under 21 CFR 866.3280.