Test, Strep, Latex Slide
FDA 510(k) K760034 · Gamma Biologicals, Inc.
510(k) numberK760034
Submission
- Device name
- Test, Strep, Latex Slide
- Applicant
- Gamma Biologicals, Inc.
Mchenry, IL, US - Received
- June 14, 1976
- Decision date
- August 11, 1976
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DEM – Alpha-1-Antitrypsin, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5130
- Specialty
- Immunology
Other 510(k)s with product code DEM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K123256 | Human ALPHA-1 Antitrypsin Kit SpaplusDEM · Traditional | The Binding Site Group , Ltd. | 07/03/2013SE |
| K063610 | Dimension Vista A1AT Flex Reagent Cartridge and Protein 1 Calibrator and Control Medium…DEM · Traditional | Dade Behring, Inc. | 01/11/2007SE |
| K053072 | N Antisera to Human ALPHA1-ANTITRYPSINDEM · Traditional | Dade Behring, Inc. | 03/28/2006SE |
| K052819 | Vitros Chemistry Products Aat Reagent, Calibrator Kit 99 and Aat Performance Verifiers…DEM · Traditional | Ortho-Clinical Diagnostics, Inc. | 12/23/2005SE |
| K050596 | Quantia A1-ATDEM · Traditional | Biokit, S.A. | 05/13/2005SE |
| K031857 | Advia Chemistry ALPHA-1 Antitrypsin AssayDEM · Traditional | Bayer Diagnostics Corp. | 09/04/2003SE |
| K011663 | Minineph A-1 Antitrypsin Antiserum, High and Low Serum ControlsDEM · Traditional | The Binding Site, Ltd. | 07/30/2001SE |
| K010978 | Tina-Quant ALPHA-1 AntitrypsinDEM · Traditional | Rochdiag | 05/18/2001SE |
| K993444 | K-Assay ALPHA-1 atDEM · Traditional | Kamiya Biomedical Co. | 11/24/1999SE |
| K972640 | Tina-Quant Alpha PARTICLE-1-ANTITRYPSIN AssayDEM · Traditional | Boehringer Mannheim Corp. | 01/09/1998SE |
More from Boehringer Mannheim Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K864207 | Disposable Test Cards/Gamma Slide Test Infect MonoKTN · Traditional | 12/03/1986SE |
| K861016 | Gamma Slide Test for Infectious MononucleosisKTN · Traditional | 04/18/1986SE |
| K832473 | Gamma Slide Test for PregnancyJHJ · Traditional | 08/16/1983SE |
| K820647 | Gamma Fetal Bleed Screening TestLIM · Traditional | 05/12/1982SE |
| K820072 | Fe-Cult PlusKHE · Traditional | 03/04/1982SE |
| K813342 | Gamma Chloroquine Diphosphate SolutionKSK · Traditional | 03/04/1982SE |
| K811752 | Fe-Cult PlusKHE · Traditional | 11/02/1981SE |
| K802534 | Gamma Pi Blood Group SubstanceKSX · Traditional | 11/12/1980SE |
| K802533 | Gamma Lewis Blood Group SubstanceKSX · Traditional | 11/12/1980SE |
| K800658 | Rst-Series ControlKSF · Traditional | 04/16/1980SE |
Questions and answers
When was Test, Strep, Latex Slide cleared by the FDA?
Test, Strep, Latex Slide (K760034) received a 510(k) decision of Substantially Equivalent on August 11, 1976, 58 days after the submission was received.
What is the product code of K760034?
The FDA product code is DEM – Alpha-1-Antitrypsin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5130.