Qualitrol Syphsero Control Set
FDA 510(k) K961998 · Consolidated Technologies, Inc.
510(k) numberK961998
Submission
- Device name
- Qualitrol Syphsero Control Set
- Applicant
- Consolidated Technologies, Inc.
Austin, TX, US - Received
- May 22, 1996
- Decision date
- August 8, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GMP – Antisera, Control For Nontreponemal Tests
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3820
- Specialty
- Microbiology
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| K974699 | Reference Material for Amphetamine/Methamphetamine in Human UrineDKB · Traditional | 01/22/1998SE |
| K973469 | Quikcheck Unassayed Chemistry Control Levels 1 and 2, Conformancemccliquichem Unassayed…JJY · Traditional | 09/25/1997SE |
| K972146 | Qualitrol Unassayed H. Pylori Control Set Positive and Negative ControlsLYR · Traditional | 07/08/1997SE |
| K972080 | Qualitrol DHP Immunoassay Control Levels 1,2 and 3, Conformancee Mcc-Ligand Control…JJY · Traditional | 06/18/1997SE |
| K961815 | Qualitrol Ana Control Serum SetLKJ · Traditional | 09/27/1996SE |
Questions and answers
When was Qualitrol Syphsero Control Set cleared by the FDA?
Qualitrol Syphsero Control Set (K961998) received a 510(k) decision of Substantially Equivalent on August 8, 1996, 78 days after the submission was received.
What is the product code of K961998?
The FDA product code is GMP – Antisera, Control For Nontreponemal Tests, a Class II (moderate risk) device regulated under 21 CFR 866.3820.