OLYMPUS PK-TP ABSORBENT KIT
FDA 510(k) clearance K905038 · decided 1991-05-06
Clearance details
- K-number
- K905038
- Device name
- OLYMPUS PK-TP ABSORBENT KIT
- Applicant
- Fujirebio America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-11-06
- Decision date
- 1991-05-06
- Days to decision
- 181 days
- Clearance type
- Traditional
- Product code
- GMT
- Device class
- 2
- Regulation number
- 866.3830
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Fairfield, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SERODIA TP-PA (K971502) | Scimedx Tekfile Services | 1997-11-13 |
| OLYMPUS PK TP(TM) SYSTEM, MODIFICATION (K911640) | Olympus Corp. | 1991-07-24 |
| MODIFIED PK TP CONTROL (K911266) | Olympus Corp. | 1991-05-07 |
| CELLOGNOST SYPHILIS H (K896410) | Behring Diagnostics, Inc. | 1990-05-15 |
| OLYMPUS PK(TM) TP (K893124) | Fujirebio Diagnostics,Inc. | 1989-11-17 |
| BACTO-HATTS (K791897) | Difco Laboratories, Inc. | 1979-11-13 |
| AGGLUTINOTEST-SYPHILIS (K791457) | Volu Sol Medical Industries | 1979-09-24 |
| REAGENT, VDRL (K760098) | Gamma Biologicals, Inc. | 1976-08-03 |
Recalls involving this device
No recalls on record reference this clearance.