FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OLYMPUS PK(TM) TP
K Number: K893124
·
Decision Nov 17, 1989
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
8
Applicant Total
20
Review Days
206
Basic Information
- Device Name
- OLYMPUS PK(TM) TP
- K Number
- K893124
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3830
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- FUJIREBIO DIAGNOSTICS, INC.
- Date Received
- April 25, 1989
- Decision Date
- November 17, 1989
- Product Code
- GMT
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GMT | Antigens, Ha, Treponema Pallidum | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GMT), ordered by most recent decision date.
SERODIA TP-PA
FDA 510(k)
FDA Class 2
·Microbiology
OLYMPUS PK TP(TM) SYSTEM, MODIFICATION
FDA 510(k)
FDA Class 2
·Microbiology
MODIFIED PK TP CONTROL
FDA 510(k)
FDA Class 2
·Microbiology
OLYMPUS PK-TP ABSORBENT KIT
FDA 510(k)
FDA Class 2
·Microbiology
CELLOGNOST SYPHILIS H
FDA 510(k)
FDA Class 2
·Microbiology
BACTO-HATTS
FDA 510(k)
FDA Class 2
·Microbiology
Other Clearances by FUJIREBIO DIAGNOSTICS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K163544 | Lumipulse G Prolactin | Jan 12, 2017 | Substantially Equivalent |
| K153361 | Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators | Apr 15, 2016 | Substantially Equivalent |
| K140436 | ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT GALECTIN-3 CONTROLS | Dec 23, 2014 | Substantially Equivalent |
| K133197 | FDI LEVEL I AND LEVEL II GLUCOSE CONTROLS FOR THE EMBRACE NO CODE | Jan 17, 2014 | Substantially Equivalent |
| K123612 | FDI GLUCOSE CONTROL SOLUTION FOR USE WITH ACCU-CHEK AVIVA | Jan 17, 2013 | Substantially Equivalent |
| K103358 | ROMA (HE4 EIA + ARCHITECT CA 125 II) | Sep 1, 2011 | Unknown |
| K103676 | FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL | Jul 19, 2011 | Substantially Equivalent |
| K092645 | FDI GLUCOSE CONTROL LEVELS 1, 2 AND 3 | Sep 5, 2009 | Substantially Equivalent |
| K080751 | ARCHITECT CYCLOSPORINE | Sep 11, 2008 | Substantially Equivalent |
| K072939 | HE4 EIA, MODEL: 404-10 US | Jun 9, 2008 | Substantially Equivalent |