510(k) K911266
- Device
- Modified Pk Tp Control
- Applicant
- OLYMPUS CORP.
- 510(k) number
- K911266
- Product code
- GMT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-05-07
- Date received
- 1991-03-15
- Regulation
- 866.3830
- Classification name
- Antigens, Ha, Treponema Pallidum
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- STORMS TYLER
- Address
- 4 Nevada Dr. Lake Success NY US 11042 11042
FDA Registration Numbers#
- 3014643041
- 3014328219
- 1643621
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GMT#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K971502 | SERODIA TP-PA | Scimedx Tekfile Services | 1997-11-13 |
| K911640 | OLYMPUS PK TP(TM) SYSTEM, MODIFICATION | Olympus Corp. | 1991-07-24 |
| K905038 | OLYMPUS PK-TP ABSORBENT KIT | Fujirebio America, Inc. | 1991-05-06 |
| K896410 | CELLOGNOST SYPHILIS H | Behring Diagnostics, Inc. | 1990-05-15 |
| K893124 | OLYMPUS PK(TM) TP | Fujirebio Diagnostics,Inc. | 1989-11-17 |
| K791897 | BACTO-HATTS | Difco Laboratories, Inc. | 1979-11-13 |
| K791457 | AGGLUTINOTEST-SYPHILIS | Volu Sol Medical Industries | 1979-09-24 |
| K760098 | REAGENT, VDRL | Gamma Biologicals, Inc. | 1976-08-03 |