Agglutinotest-Syphilis
FDA 510(k) K791457 · Volu Sol Medical Industries
510(k) numberK791457
Submission
- Device name
- Agglutinotest-Syphilis
- Applicant
- Volu Sol Medical Industries
Mchenry, IL, US - Received
- August 6, 1979
- Decision date
- September 24, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GMT – Antigens, Ha, Treponema Pallidum
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3830
- Specialty
- Microbiology
Other 510(k)s with product code GMT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K971502 | Serodia Tp-PaGMT · Traditional | Scimedx Tekfile Services | 11/13/1997SE |
| K911640 | Olympus PK Tp(Tm) System, ModificationGMT · Traditional | Olympus Corp. | 07/24/1991SE |
| K911266 | Modified PK TP ControlGMT · Traditional | Olympus Corp. | 05/07/1991SE |
| K905038 | Olympus Pk-Tp Absorbent KitGMT · Traditional | Fujirebio America, Inc. | 05/06/1991SE |
| K896410 | Cellognost Syphilis HGMT · Traditional | Behring Diagnostics, Inc. | 05/15/1990SE |
| K893124 | Olympus Pk(Tm) TPGMT · Traditional | Fujirebio Diagnostics,Inc. | 11/17/1989SE |
| K791897 | Bacto-HattsGMT · Traditional | Difco Laboratories, Inc. | 11/13/1979SE |
| K760098 | Reagent, VDRLGMT · Traditional | Gamma Biologicals, Inc. | 08/03/1976SE |
More from Gamma Biologicals, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K822129 | Volu-Sol Bovins FixativeIGN · Traditional | 08/05/1982SE |
| K822128 | Volu-Sol Single Differential StainICN · Traditional | 08/05/1982SE |
| K822127 | Volu-Sol Zenkers FixativeIFH · Traditional | 08/05/1982SE |
| K822126 | Volu-Sol Carnoy FluidIGM · Traditional | 08/05/1982SE |
| K822038 | Volu-Sol Orange G-6(GILLS-MODHZH · Traditional | 08/03/1982SE |
| K822037 | Volu-Sol Tap Water SubstitutePPM · Traditional | 08/03/1982SE |
| K822036 | Volu-Sol DecalciferKDX · Traditional | 08/03/1982SE |
| K822035 | Volu-Sol Gills EaHZJ · Traditional | 08/03/1982SE |
| K812906 | Elvi Biclot 816KQG · Traditional | 07/22/1982SE |
| K821541 | Hematoxylin IIIHYJ · Traditional | 06/10/1982SE |
Questions and answers
When was Agglutinotest-Syphilis cleared by the FDA?
Agglutinotest-Syphilis (K791457) received a 510(k) decision of Substantially Equivalent on September 24, 1979, 49 days after the submission was received.
What is the product code of K791457?
The FDA product code is GMT – Antigens, Ha, Treponema Pallidum, a Class II (moderate risk) device regulated under 21 CFR 866.3830.