SAS HCG Serum Controls
FDA 510(k) K990720 · Sa Scientific, Inc.
510(k) numberK990720
Submission
- Device name
- SAS HCG Serum Controls
- Applicant
- Sa Scientific, Inc.
San Antonio, TX, US - Received
- March 5, 1999
- Decision date
- March 19, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JJX – Single (Specified) Analyte Controls (Assayed And Unassayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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| 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 HCG Serum Controls cleared by the FDA?
SAS HCG Serum Controls (K990720) received a 510(k) decision of Substantially Equivalent on March 19, 1999, 14 days after the submission was received.
What is the product code of K990720?
The FDA product code is JJX – Single (Specified) Analyte Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.