Olympus Pk-Tp Absorbent Kit
FDA 510(k) K905038 · Fujirebio America, Inc.
510(k) numberK905038
Submission
- Device name
- Olympus Pk-Tp Absorbent Kit
- Applicant
- Fujirebio America, Inc.
Fairfield, NJ, US - Received
- November 6, 1990
- Decision date
- May 6, 1991
- 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 |
| 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 |
| K791457 | Agglutinotest-SyphilisGMT · Traditional | Volu Sol Medical Industries | 09/24/1979SE |
| K760098 | Reagent, VDRLGMT · Traditional | Gamma Biologicals, Inc. | 08/03/1976SE |
More from Gamma Biologicals, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K953066 | Serodia AtgDDC · Traditional | 08/14/1995SE |
Questions and answers
When was Olympus Pk-Tp Absorbent Kit cleared by the FDA?
Olympus Pk-Tp Absorbent Kit (K905038) received a 510(k) decision of Substantially Equivalent on May 6, 1991, 181 days after the submission was received.
What is the product code of K905038?
The FDA product code is GMT – Antigens, Ha, Treponema Pallidum, a Class II (moderate risk) device regulated under 21 CFR 866.3830.